FDA 510(k) Applications for Medical Device Product Code "KDI"
(Dialyzer, High Permeability With Or Without Sealed Dialysate System)

FDA 510(k) Number Applicant Device Name Decision Date
K911094 ABBOTT LABORATORIES INPERSOL CAPD BIOCAP ADMINISTRATION SET 04/16/1991
K855251 ADVOCACY INTERNATIONAL, LTD. MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS 02/04/1986
K010131 AKSYS, LTD. PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB 03/26/2002
K992563 ALTHIN MEDICAL AB A-22 HEMODIALYZER 01/18/2000
K992566 ALTHIN MEDICAL AB AF-150 HEMODIALYZER 01/18/2000
K992564 ALTHIN MEDICAL AB AF-180 HEMODIALYZER 01/18/2000
K992573 ALTHIN MEDICAL AB AF-220 HEMODIALYZER 01/18/2000
K952983 ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL ALTR NOVA 110 HEMODIALYZER 10/05/1995
K952978 ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL ALTRA FLUX 110 HEMODIALYZER 10/05/1995
K926373 ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL ALTRA FLUX 200 HEMODIALYZER 02/13/1995
K945620 ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL ALTRA FLUX(TM) 140 HEMODIALYZER 05/18/1995
K945542 ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL ALTRA FLUX(TM) 170 HEMODIALYZER 05/23/1995
K926379 ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL ALTRA NOVA 200 HEMODAILYZER 02/13/1995
K945625 ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL ALTRA NOVA(TM) 140 HEMODIALYZER 05/30/1995
K945621 ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL ALTRA NOVA(TM) 170 HEMODIALYZER 05/30/1995
K954987 ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM 08/08/1996
K945596 ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL ALTRES(R) 140 HEMODIALYZER 03/08/1995
K945597 ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL ALTRES(R) 170 HEMODIALYZER 03/08/1995
K952982 ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL ALTREX 110 HEMODIALYZER 10/05/1995
K945595 ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL ALTREX(R) 200 HEMODIALYZER 03/08/1995
K970446 ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM 06/02/1997
K964922 ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM 05/21/1997
K955384 ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION 01/10/1997
K913950 ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY 11/01/1991
K990643 ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015 12/07/1999
K841585 AMERICAN BENTLEY AMER. BENTLEY CONTINU-BLOOD PROCESSOR- 10/18/1984
K902837 AMICON, INC. AMICON DIAFILTER 30 HEMOCONCENTRATOR 11/01/1990
K863823 AMICON, INC. AMICON DIAFILTER HEMOFILTER 11/06/1986
K823288 AMICON, INC. AMICON DIAFILTERS 20 & 30 HEMOFILTERS 12/16/1982
K901286 AMICON, INC. AMICON HEMOCONCENTRATOR SET 05/18/1990
K895405 AMICON, INC. AMICON MINIFILTER PLUS HEMOFILTER 01/11/1990
K823881 AMICON, INC. ARTERIOVENOUS BLOOD TUBING SET FOR 01/17/1983
K813591 AMICON, INC. HEMOFILTERS 03/31/1982
K853510 AMICON, INC. MINIFILTER HEMOFILTER 09/12/1985
K153344 Asahi Kasei Medical Co., Ltd. Asahi REXEED-S Series Dialyzer 12/17/2015
K082515 ASAHI KASEI MEDICAL CO., LTD. ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX 10/03/2008
K121409 ASAHI KASEI MEDICAL CO., LTD. ASAHI REXEED-SX/LX SERIES DIALYZER 02/06/2013
K162248 ASAHI KASEI MEDICAL CO., LTD. Asahi ViE-U Series Dialyzer 05/03/2017
K051187 ASAHI KASEI MEDICAL CO., LTD. REXEED SERIES DIALYZERS 06/08/2005
K013418 ASAHI MEDICAL CO., LTD AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY 07/09/2002
K001250 ASAHI MEDICAL CO., LTD. APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS) 08/16/2000
K844663 ASAHI MEDICAL CO., LTD. ASAHI NEW PAN-SERIES HEMOFILTERS 01/18/1985
K041726 ASAHI MEDICAL CO., LTD. HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX 07/23/2004
K914020 ASAHI MEDICAL CO., LTD. MODIFIED ASAHI PAN-SERIES HEMOFILTERS 03/20/1992
K100334 B. BRAUN AVITUM AG DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811 04/22/2010
K170574 B. Braun Avitum AG Diacap Pro Dialyzer 08/11/2017
K083460 B. BRAUN AVITUM AG DIALOG WITH ADIMEA OPTION 02/18/2010
K143482 B. Braun Avitum AG xevonta dialyzer 03/01/2016
K963440 B. BRAUN MEDICAL AG DIALOG DIALYSIS MACHINE 06/26/1998
K973322 B. BRAUN MEDICAL, INC. DIAPACT CRRT 11/10/1998
K071518 B. BRAUN MEDIZINTECHNOLOGIE GMBH DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS 08/17/2007
K163530 BAXTER HEALTHCARE CORP PrisMax Control Unit 05/03/2017
K013562 BAXTER HEALTHCARE CORP. AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE 12/12/2002
K021615 BAXTER HEALTHCARE CORP. BAXTER ACCURA SYSTEM, MODEL 5M5660 11/18/2002
K030099 BAXTER HEALTHCARE CORP. BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000 06/17/2003
K926568 BAXTER HEALTHCARE CORP. BAXTER CT DIALYZER 09/30/1994
K963203 BAXTER HEALTHCARE CORP. BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT 03/25/1997
K970591 BAXTER HEALTHCARE CORP. BLOOD MONITOR PUMP 09/09/1997
K974652 BAXTER HEALTHCARE CORP. BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER 07/10/1998
K950522 BAXTER HEALTHCARE CORP. CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER 04/27/1995
K890315 BAXTER HEALTHCARE CORP. CAPILLARY FLOW DIALYZERS MODELS CT110G & CT190G 02/08/1989
K895631 BAXTER HEALTHCARE CORP. DISCONNECT CAPS PRODUCT CODES 5C4212 AND 5C4466 01/29/1990
K030974 BAXTER HEALTHCARE CORP. EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170 04/25/2003
K030975 BAXTER HEALTHCARE CORP. EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210 04/25/2003
K992894 BAXTER HEALTHCARE CORP. MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 11/24/1999
K980656 BAXTER HEALTHCARE CORP. PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236 05/19/1998
K001422 BAXTER HEALTHCARE CORP. PSN HEMODIALYZER, MODELS PSN 170, PSN 210 06/02/2000
K023664 BAXTER HEALTHCARE CORP. SYNTRA + DIALYZER, MODEL 200 02/21/2003
K002210 BAXTER HEALTHCARE CORP. SYNTRA DIALYZER, MODEL SYNTRA 120, 160 02/14/2001
K053539 BAXTER HEALTHCARE CORPORATION MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 05/24/2006
K171671 Baxter Healthcare Corporation Prismaflex System 8.10 02/23/2018
K062079 BAXTER HEALTHCARE CORPORATION XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210 10/19/2006
K083778 BAXTER HEALTHCARE CORPORATION XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210 02/20/2009
K093120 BAXTER HEALTHCARE CORPORATION - RENAL DIVISION XENIUM XPM 110, XENIUM XPM 130, MODELS M25649A, M25650A, XENIUM XPM 150, XENIUM XPM 170 02/17/2010
K160558 BELLCO Srl RAPIDO HOLLOW-FIBRE DIALYZERS 11/18/2016
K820243 BENTLEY LABORATORIES, INC. CONTINUOUS BLOOD PROCESSOR CBP-6000 & 03/25/1982
K903641 BENTLEY LABORATORIES, INC. QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q 11/09/1990
K093379 BL HEALTHCARE, INC. TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM 02/09/2010
K920757 C.G.H. MEDICAL, INC. FILTRAL HEMODIALYZERS 08/05/1994
K933818 C.G.H. MEDICAL, INC. GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER 01/25/1995
K911603 C.G.H. MEDICAL, INC. HEMOSPAL KIT B22 08/07/1991
K924437 C.G.H. MEDICAL, INC. HEMOSPAL KIT B22 / MULTIFLOW 60 KIT 06/27/1994
K931720 C.G.H. MEDICAL, INC. LUNDIA ALPHA 700 HEMODIALYZER 07/07/1994
K971180 C.R. BARD, INC. BARD NO-RINSE HEMOCONCENTRATOR AND ACCESSORY KIT 07/24/1997
K884353 CD MEDICAL, INC. ULTRX(TM) 850 ARTIFICIAL KIDNEY 12/08/1988
K060008 CHF SOLUTIONS, INC. AQUADEX FLEXFLOW SYSTEM 02/02/2006
K071854 CHF SOLUTIONS, INC. AQUADEX FLEXFLOW SYSTEM 09/07/2007
K050609 CHF SOLUTIONS, INC. AQUADEX SYSTEM 11/09/2005
K040489 CHF SOLUTIONS, INC. AQUADEX SYSTEM 100, MODEL A1100 04/27/2004
K023224 CHF SOLUTIONS, INC. INFUSION CATHETER EXTENSION SET 10/25/2002
K062922 CHF SOLUTIONS, INC. MODIFICATION TO AQUADEX FLEXFLOW SYSTEM 12/13/2006
K070512 CHF SOLUTIONS, INC. MODIFICATION TO AQUADEX FLEXFLOW SYSTEM 04/27/2007
K023874 CHF SOLUTIONS, INC. SYSTEM 100 ULTRAFILTRATION CATHETER 11/20/2003
K024124 CHF SOLUTIONS, INC. SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT 03/14/2003
K013733 CHF SOLUTIONS, INC. SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET 06/03/2002
K840680 COBE LABORATORIES, INC. CENTRY 2000 DIALYSIS CONTROL UNIT 04/20/1984
K823338 COBE LABORATORIES, INC. COBE HEMOCONCENTRATOR 1.3 01/07/1983
K955592 COBE RENAL CARE, INC. COBE CENTRYSYSTEM 14 PES HEMODIALYZERS 04/30/1997
K960474 COBE RENAL CARE, INC. COBE CENTRYSYSTEM 600 HG HEMODIALYZERS 08/14/1996
K933883 COBE RENAL CARE, INC. GAMBRO FH 66 D HEMOFILTER 03/13/1995
K951311 COBE RENAL CARE, INC. GAMBRO HC 14R HEMOCONCENTRATOR 01/11/1996
K945747 COBE RENAL CARE, INC. GAMBRO LUNDIA 94-600 DIALYZER 09/08/1995
K952342 COBE RENAL CARE, INC. GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS 09/15/1995
K955487 COBE RENAL CARE, INC. GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS 04/18/1997
K946279 COBE RENAL CARE, INC. PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) 02/10/1997
K801731 CORDIS CORP. C-DAK DUO-FLUX ARTIFICIAL KIDNEY 08/13/1980
K811830 CORDIS CORP. C-DAK DUO-FLUX ARTIFICIAL KIDNEY 09/21/1981
K023509 DAVITA CLINICAL RESEARCH (TRRI) DBB-05 HEMODIALYSIS DELIVERY SYSTEM 10/30/2003
K021732 DIDECO S.P.A. DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT 11/04/2002
K982134 DYNAMIC TECHNOLOGY CORP. DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851 04/14/1999
K011537 DYNAMIC TECHNOLOGY CORP. DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS, POLYSULFONE 130 HFS 01/07/2002
K070320 EDWARDS LIFESCIENCES SERVICES GMBH EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01 06/07/2007
K090682 EDWARDS LIFESCIENCES SERVICES GMBH EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00 11/19/2009
K850866 ERIKA, INC. TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L 04/03/1985
K832547 EXTRACORPOREAL MEDICAL SPECIALITIES, INC. ULTRAFILTRATION CONTROLLER 01/03/1984
K994267 FRESENIUS MEDICAL CARE FRESENIUS 2008K 03/16/2000
K111639 FRESENIUS MEDICAL CARE FRESENIUS 2008T HEMODIALYSIS MACHINE 10/21/2011
K113427 FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS 2008T HEMODIALYSIS MACHINE 12/21/2011
K982926 FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS BLOOD VOLUME MONITOR 09/03/1999
K080964 FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE 01/14/2009
K991520 FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION 07/30/1999
K003498 FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS OPTIFLUX 200A 01/04/2001
K002277 FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS OPTIFLUX 200NR 08/25/2000
K043244 FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR 12/20/2004
K070222 FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N 04/24/2007
K034064 FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS ULTRAFLO HPX HEMODIALYZER 01/30/2004
K031378 FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS ULTRAFLUX HEMODIALYZER 05/30/2003
K093902 FRESENIUS MEDICAL CARE NORTH AMERICA MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573 05/27/2010
K162488 FRESENIUS MEDICAL CARE NORTH AMERICA Optiflux dialyzer 04/06/2017
K152367 FRESENIUS MEDICAL CARE NORTH AMERICA Optiflux dialyzer 10/29/2015
K082414 FRESENIUS MEDICAL CARE NORTH AMERICA OPTIFLUX F250NR, MODEL 0500325E 10/28/2008
K123262 FRESENIUS MEDICAL CARE NORTH AMERICA OPTIFLUX ULTRA DIALYZER 01/06/2014
K120505 FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE FRESENIUS 2008T HEMODIALYSIS MACHINE 03/06/2012
K101715 FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 12/21/2010
K150708 FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine 12/10/2015
K153449 FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC 2008K2 Hemodialysis Machine 04/26/2016
K173972 Fresenius Medical Care Renal Therapies Group, LLC 2008T BlueStar Hemodialysis Machine 05/10/2018
K131908 FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC 2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC) 10/11/2013
K120017 FRESENIUS MEDICAL CARE, NORTH AMERICA FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM 02/02/2012
K121341 FRESENIUS MEDICAL CARE, NORTH AMERICA FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM 12/06/2012
K133299 FRESENIUS MEDICAL CARE, NORTH AMERICA - RENAL THER ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY 07/07/2014
K961465 FRESENIUS USA, INC. 2008H ON LINE CLEARANCE MONITOR 07/03/1997
K974584 FRESENIUS USA, INC. FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS 05/14/1998
K883195 FRESENIUS USA, INC. FRESENIUS F8 DIALYZER 09/13/1988
K892262 FRESENIUS USA, INC. FRESENIUS HEMOFLOW, F40M, F50M, F60M & F80M 04/25/1989
K992275 FRESENIUS USA, INC. FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS 08/04/1999
K921134 FRESENIUS USA, INC. FRESENIUS POLYSULFONE DIALYZERS 12/02/1993
K072093 GAMBRO PRISMAFLEX SYSTEM, VERSION 3.20 02/01/2008
K982413 GAMBRO HEALTHCARE COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS 04/21/1999
K982760 GAMBRO HEALTHCARE COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET 11/04/1998
K970253 GAMBRO HEALTHCARE COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET 09/26/1997
K962427 GAMBRO HEALTHCARE COBE CENTRYSYSTEM 700 HG HEMODIALYZER 09/20/1996
K982414 GAMBRO HEALTHCARE GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS 03/26/1999
K980386 GAMBRO HEALTHCARE HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0) 02/24/1999
K981681 GAMBRO HEALTHCARE PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) 08/11/1998
K030592 GAMBRO RENAL CARE PRODUCTS GAMBRO POLYFLUX, MODEL 140H, 170H, 210H 05/23/2003
K993064 GAMBRO RENAL CARE PRODUCTS PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) 10/06/1999
K010985 GAMBRO RENAL PRODUCTS GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L 10/10/2001
K010667 GAMBRO RENAL PRODUCTS GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R 06/04/2001
K060195 GAMBRO RENAL PRODUCTS GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE 04/24/2006
K051520 GAMBRO RENAL PRODUCTS GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H 12/09/2005
K041005 GAMBRO RENAL PRODUCTS GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS 10/07/2004
K042938 GAMBRO RENAL PRODUCTS GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS 01/06/2005
K001156 GAMBRO RENAL PRODUCTS PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET 07/07/2000
K011221 GAMBRO RENAL PRODUCTS PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET 10/31/2001
K010805 GAMBRO RENAL PRODUCTS PRISMA SYSTEM 08/06/2002
K062090 GAMBRO RENAL PRODUCTS PRISMA SYSTEM R03.10A 10/18/2006
K072232 GAMBRO RENAL PRODUCTS, INC. GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL 09/07/2007
K103832 GAMBRO RENAL PRODUCTS, INC. PHOENIX HEMODIALYSIS DELIVERY SYSTEM 05/20/2011
K040255 GAMBRO RENAL PRODUCTS, INC. POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE 05/24/2004
K063183 GAMBRO RENAL PRODUCTS, INC. PRISMA M10 PRE SET 02/15/2007
K110823 GAMBRO RENAL PRODUCTS, INC. PRISMAFLEX 06/17/2011
K080519 GAMBRO RENAL PRODUCTS, INC. PRISMAFLEX M150 SET 06/13/2008
K131516 GAMBRO RENAL PRODUCTS, INC. PRISMAFLEX SYSTEM 7.10 01/03/2014
K130039 GAMBRO RENAL PRODUCTS, INC. REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER 05/02/2013
K840543 GAMBRO, INC. BLOOD CONCENTRATOR 140 03/23/1984
K083158 GAMBRO, INC. EXALIS, SOFTWARE VERSION 1.15 06/05/2009
K830284 GAMBRO, INC. FH 101, FH 202 & FH 303 FIBER HEMOFILTER 03/02/1983
K854309 GAMBRO, INC. GAMBRO BLOOD CONCENTRATOR SETS 16,60,200 12/13/1985
K860938 GAMBRO, INC. GAMBRO FIBER HEMOFILTERS FH 22/66 DISPOS TUBE SETS 04/07/1986
K900918 GAMBRO, INC. GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER 07/16/1990
K801480 GAMBRO, INC. GAMBRO LUNDIA MAJOR HIGH FLUX HEMODIALYZ 08/27/1980
K811944 GAMBRO, INC. GAMBRO LUNDIA PLATE HIGH FLUX DIALYZER 08/31/1981
K801479 GAMBRO, INC. GAMBRO LUNDIA PLATE HIGH FLUX HEMODIAL- 08/27/1980
K871108 GAMBRO, INC. GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER 05/15/1987
K831784 GAMBRO, INC. HEMOFILTRATION SYSTEM 02/04/1984
K070643 GAMBRO, INC. PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35 11/02/2007
K032431 GAMBRO, INC. PRISMA M60/M100 SETS 09/15/2003
K830596 GAMBRO, INC. ULTRAFILTRATION MONITOR UFM-10-2 04/27/1983
K140866 HOME DIALYSIS PLUS TABLO CONSOLE 09/10/2014
K003023 HOSPAL INDUSTRIE COBE HC 700 MIDI HEMOCONCENTRATOR 04/30/2001
K834589 HOSPAL MEDICAL CORP. BIOSPAL (R) 1800S 02/04/1984
K832659 HOSPAL MEDICAL CORP. BIOSPAL 1200S 09/20/1983
K832645 HOSPAL MEDICAL CORP. BIOSPAL 3000 S 09/20/1983
K883307 HOSPAL MEDICAL CORP. CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT 10/12/1988
K780527 HOSPAL MEDICAL CORP. CORTRAL I 12/20/1978
K872767 HOSPAL MEDICAL CORP. FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER 12/29/1987
K852885 HOSPAL MEDICAL CORP. FILTRAL HEMODIALYZER 09/06/1985
K893742 HOSPAL MEDICAL CORP. FILTRAL TM 20 HEMODIALYZER/FILTER 07/24/1989
K884326 HOSPAL MEDICAL CORP. FILTRAL TM 8 HEMODIALYZER 12/05/1988
K823589 HOSPAL MEDICAL CORP. H 12 07 12/22/1982
K830648 HOSPAL MEDICAL CORP. H1207 03/29/1983
K830647 HOSPAL MEDICAL CORP. H1210 03/29/1983
K781464 HOSPAL MEDICAL CORP. HEMODIALYZER, MODEL RP610, RP AN 69 12/20/1978
K863961 HOSPAL MEDICAL CORP. HOSPAL BIOSPAL 1800S 12/17/1986
K841152 HOSPAL MEDICAL CORP. HOSPAL BIOSPAL SCU/CAVH KIT 07/06/1984
K800536 HOSPAL MEDICAL CORP. MODEL H 607-.67M2 30 MICRON RP AN69 MEM 08/07/1980
K812575 HOSPAL MEDICAL CORP. MODEL H12-10 10/19/1981
K830595 HOSPAL MEDICAL CORP. MONITRAL 04/28/1983
K884365 HOSPAL MEDICAL CORP. MULTIFLOW(TM) 60 KIT 12/08/1988
K790827 HOSPAL MEDICAL CORP. RP-610 PARALLEL PLATE DIALYZER 09/04/1979
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K123288 MAQUET CARDIOPULMONARY AG HEMOCONCENTRATOR 06/26/2013
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K840449 MEDICAL DEVICE CONSULTANTS, INC. AMICON DIAFILTER 40. HEMOFILTER 03/23/1984
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K071298 MINNTECH CORP. HF JUNIOR HEMOFILTER 08/08/2007
K923312 MINNTECH CORP. HIGH PERMEABILITY DIALYER 02/18/1994
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K962707 MINNTECH CORP. MINNTECH MINNIFILTER PLUS HEMOFILTER AND TUBING SET 10/09/1996
K923727 MINNTECH CORP. PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000 07/29/1994
K910236 MINNTECH CORP. RENAFLO HDF 1350 HEMODIAFILTER 04/09/1991
K000028 MINNTECH CORP. RENAFLO II HF 2000 HEMOFILTER 04/04/2000
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K091978 NIKKISO CO. LTD. DBB-06 HEMODIALYSIS DELIVERY SYSTEM 03/25/2010
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K152938 NIKKISO, CO.,LTD. DBB-06 Hemodialysis Delivery System 03/18/2016
K122347 NIPRO MEDICAL CORPORATION ELISIO-H AND ELISIO-M HEMODIALYZERS 05/01/2013
K140191 NIPRO MEDICAL CORPORATION ELISIO-H HEMODIALYZER 04/14/2014
K131381 NIPRO MEDICAL CORPORATION ELISIO-H HEMODIALYZER 12/19/2013
K131935 NIPRO MEDICAL CORPORATION ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER 12/20/2013
K160444 NIPRO MEDICAL CORPORATION FB-U Hemodialyzer 02/08/2017
K122343 NIPRO MEDICAL CORPORATION PUREFLUX-H HEMODIALYZER 05/07/2013
K170469 NxStage Medical, Inc NxStage System One Plus 05/09/2017
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K014152 NXSTAGE MEDICAL, INC. NXSTAGE CARTRIDGE EXPRESS 12/11/2002
K061837 NXSTAGE MEDICAL, INC. NXSTAGE CARTRIDGE EXPRESS 07/31/2006
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K132602 NXSTAGE MEDICAL, INC. STREAMLINE EXPRESS 02/04/2014
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K150880 Outset Medical Tablo Console with Wireless Capability 05/01/2015
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K861106 SERATRONICS, INC. FRESENIUS HEMOFLOW F80 DIALYZER 04/07/1986
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K081313 SORIN GROUP ITALIA S.R.L. SH14 HEMOCONCENTRATOR 11/19/2008
K170790 Spectral Medical Inc. SAM CRRT Unit, SAM Cassette CRRT 12/13/2017
K973516 TERUMO MEDICAL CORP. CAPIOX HEMOCONCENTRATOR 01/30/1998
K013550 TERUMO MEDICAL CORP. CLIRANS E-SERIES DIALYZER 11/20/2001
K003425 TERUMO MEDICAL CORP. CLIRANS E-SERIES HOLLOW FIBER DIALYZERS 02/01/2001
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K994198 TORAY INDUSTRIES (AMERICA), INC. HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L 08/25/2000
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K080650 TRANSVIVO INC. OMNI-DL SYSTEM 11/26/2008
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