FDA 510(k) Applications for Medical Device Product Code "DTN"
(Reservoir, Blood, Cardiopulmonary Bypass)

FDA 510(k) Number Applicant Device Name Decision Date
K862357 3M HEALTH CARE, SARNS MODIFIED CARDIOTOMY RESERVOIR 5M1470 08/19/1986
K883345 3M HEALTH CARE, SARNS SARNS INFANT VENOUS RESERVOIR MODEL #16387 09/28/1988
K870829 3M HEALTH CARE, SARNS SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESERVOIR 05/06/1987
K072697 3T MEDICAL SYSTEMS, LLC 3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES 12/20/2007
K841938 AMERICAN BENTLEY CARDIOPLEGIA RESERVOIR CAS-2000 08/03/1984
K831966 AMERICAN BENTLEY CARDIOPLEGIA RESERVOIR-#500926 08/11/1983
K844366 AMERICAN BENTLEY CARDIOTOMY RESERVOIR BCR-2000 01/14/1985
K844367 AMERICAN BENTLEY CARDIOTOMY RESERVOIR W/FILTER BCR-2500 01/14/1985
K842620 AMERICAN BENTLEY CARDIOTOMY RESERVOIR W/FILTER BCR-3500 08/27/1984
K834373 AMERICAN BENTLEY CARDIOTOMY RESERVORS BCR-3000/3500-Q-120 02/04/1984
K852382 AMERICAN BENTLEY CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR 09/25/1985
K841031 AMERICAN BENTLEY OXYHI CRYSTALLOID CARDIOPLEGIA SOLUT 05/23/1984
K832802 AMERICAN BENTLEY USE OF TWEEN 80 AS A WETTING AGENT ON 12/29/1983
K851376 AMERICAN BENTLEY VENOUS RESERVOIR BAG BMR-1600 06/25/1985
K851401 AMERICAN BENTLEY VENUOS RESERVOIR BAG BMR-1900 06/25/1985
K936003 AVECOR CARDIOVASCULAR, INC. AFFINITY CVR 06/20/1994
K935717 AVECOR CARDIOVASCULAR, INC. AFFINITY VENOUS RESERVIOR BAG 05/10/1994
K971105 AVECOR CARDIOVASCULAR, INC. MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM 07/11/1997
K913915 BARD CARDIOSURGERY DIV BARD(R) WILLIAM HARVEY(R) MACRO FILT CARDIO RESERV 01/21/1992
K974155 BAXTER HEALTHCARE CORP. BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT 01/22/1998
K895356 BAXTER HEALTHCARE CORP. UNIVOX-IC 03/06/1990
K933713 BAXTER HEALTHCARE CORP. VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT 03/01/1994
K896414 BAXTER HEALTHCARE CORP. VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN 01/31/1990
K915573 BAXTER HEALTHCARE CORP. VENOUS RESERVOIR W/CARDIOTOMY FILTER 12/23/1992
K913956 BENTLEY LABORATORIES, INC. BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30 01/17/1992
K812009 BENTLEY LABORATORIES, INC. CARDIOTOMY RESERVOIR W/FILTER#BCR-3500 07/28/1981
K812008 BENTLEY LABORATORIES, INC. CORDIOTOMY RESERVOIR 07/28/1981
K790635 BENTLEY LABORATORIES, INC. Q220F CARDITOMY RESERVOIR/MODIFIED 04/18/1979
K823272 BENTLEY LABORATORIES, INC. VENOUS RESERVOIR BAG #BMR-1400 12/30/1982
K913692 BENTLEY LABORATORIES, INC. VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM) 11/15/1991
K981628 C.R. BARD, INC. BARD QUANTUM SVR MODEL NUMBER H-6440VR 08/05/1998
K862920 C.R. BARD, INC. BARD WILLIAM HARVEY CARDIOTOMY RESERVOIR 09/29/1986
K930299 C.R. BARD, INC. BARD(R) BLOOD CARDIOPLEGIA HEAT EXCHANGER/TUBE SET 06/22/1993
K781577 C.R. BARD, INC. DISPOSABLE CARDIOTOMY; H-700F, H-700 09/27/1978
K904040 C.R. BARD, INC. SOFTSHELL VENOUS RESERVOIR 12/06/1990
K821442 C.R. BARD, INC. WILLIAM HARVEY FLEX. VENOUS RESERVOIR 06/17/1982
K841079 C.R. BARD, INC. WILLIAM HARVEY H-4700 FILTER/CARDIO 04/17/1984
K841175 C.R. BARD, INC. WILLIAM HARVEY H-4720 NON-FILTERED CAR 04/25/1984
K833479 C.R. BARD, INC. WILLIAM HARVEY H-71-5-F CARDIOTOMY 12/16/1983
K872378 C.R. BARD, INC. WILLIAM HARVEY HARDSHELL VENOUS RESERVOIR 09/14/1987
K971013 CHASE MEDICAL, INC. CHASE TEMPERATURE PROBE 10/28/1997
K981284 CIRCULATORY TECHNOLOGY, INC. BETTER-BLADDER (BB) 08/12/1998
K140321 CIRCULATORY TECHNOLOGY, INC. INITARY BETTER BLADDER-PEDIATRIC 04/17/2014
K012942 CIRCULATORY TECHNOLOGY, INC. THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500 11/05/2001
K001822 CIRCULATORY TECHNOLOGY, INC. THE V-BAG 07/07/2000
K980786 COBE CARDIOVASCULAR, INC. COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 1800 08/24/1998
K994389 COBE CARDIOVASCULAR, INC. COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED 03/27/2000
K971669 COBE CARDIOVASCULAR, INC. COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR 07/23/1997
K984456 COBE CARDIOVASCULAR, INC. COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR 01/11/1999
K993001 COBE CARDIOVASCULAR, INC. COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED 12/03/1999
K990239 COBE CARDIOVASCULAR, INC. COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR 05/25/1999
K920312 COBE CARDIOVASCULAR, INC. NEW COBE CARDIOPLEGIA SYSTEM 10/01/1992
K050111 COBE CARDIOVASCULAR, INC. SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG 03/08/2005
K033641 COBE CARDIOVASCULAR, INC. SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800 12/11/2003
K832671 COBE LABORATORIES, INC. CARDIOTOMY RESERVOIR-FILTER 050-108-050 12/27/1983
K895076 COBE LABORATORIES, INC. CMS VRB-1200 11/03/1989
K902631 COBE LABORATORIES, INC. COBE ICU CONVERSION KIT 12/17/1990
K925046 DEKNATEL, INC. PLEUR-EVAC CARDIOTOMY RESERVOIR 04/20/1993
K770546 DELTA MEDICAL INDUSTRIES BLOOD RESERVOIR 04/26/1977
K992599 DIDECO S.P.A. DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR 11/01/1999
K001602 DIDECO S.P.A. DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.) 06/08/2000
K033714 DIDECO S.P.A. MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING 12/11/2003
K842391 ELECTROMEDICS, INC. ACR 2500 CARDIOTOMY RESERVOIR FILTER 05/21/1985
K915737 ELECTROMEDICS, INC. AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR 09/03/1992
K930154 ELECTROMEDICS, INC. EL2-SERIES BLOOD COLLECTION REERVOIR 07/01/1993
K926250 ELECTROMEDICS, INC. ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR 02/19/1993
K812455 ELECTROMEDICS, INC. SUCKER CARDIOTOMY RETURN, C.P. BYPASS 10/23/1981
K820727 ERIK PERFUSION SERVICES CARDIOTOMY RESERVOIRS 07/08/1982
K823205 EXTRACORPOREAL MEDICAL SPECIALITIES, INC. EXV VENOUS RESERVOIR BAG & HOLDER 11/24/1982
K803059 EXTRACORPOREAL MEDICAL SPECIALITIES, INC. INTERSEPT* VENOUS RESERVOIR BAG & HOLDER 12/22/1980
K984586 FRESENIUS HEMOTECHNOLOGY, INC. FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS 06/29/1999
K802890 GICS PHARMACEUTICALS CPS-1000 03/05/1981
K936286 GISH BIOMEDICAL, INC. ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER) 02/14/1994
K882414 GISH BIOMEDICAL, INC. BLOOD RESERVOIR, CARDIOPULMONARY BYPASS 12/05/1988
K843888 GISH BIOMEDICAL, INC. CARDIOTOMY RESERVOIR BRS-XXX SERIES & 02/14/1985
K883923 GISH BIOMEDICAL, INC. CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES 11/04/1988
K051606 GISH BIOMEDICAL, INC. GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING 08/12/2005
K964973 GISH BIOMEDICAL, INC. GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR 03/10/1997
K030726 GISH BIOMEDICAL, INC. GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING 05/30/2003
K081947 GISH BIOMEDICAL, INC. GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING 02/04/2009
K082082 GISH BIOMEDICAL, INC. GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING 02/04/2009
K091062 GISH BIOMEDICAL, INC. MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730 08/04/2009
K083131 GISH BIOMEDICAL, INC. MEDOS HILITE RESERVOIR, MODEL: 4030 07/30/2009
K955046 GISH BIOMEDICAL, INC. SOFT VENOUS RESERVOIR 01/11/1996
K024065 GISH BIOMEDICAL, INC. SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING 03/05/2003
K871775 GISH BIOMEDICAL, INC. STAT-VAC CHEST DRAINAGE SYSTEM 06/24/1987
K050195 GISH BIOMEDICAL, INC. V-BAG WITH GBS COATING 03/17/2005
K844229 GISH BIOMEDICAL, INC. VENOUS RESERVOIR VRS-XXX SERIES; HOLDER VRS-HXX 01/14/1985
K031150 GLOBAL BLOOD RESOURCES, LLC HEMOBAG, MODEL HBBSD2000 06/23/2003
K864895 JOHNSON & JOHNSON PROFESSIONALS, INC. INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER 02/19/1987
K873423 JOHNSON & JOHNSON PROFESSIONALS, INC. MAXIMA* COLLAPSIBLE VENOUS RESERVOIR BAG & HOLDER 11/06/1987
K003551 JOSTRA AG VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201 07/11/2001
K905818 JTL MEDICAL CORP. VACUUM-ASSISTED BLOOD COLLECTION SYSTEM 06/06/1991
K920178 LIFESTREAM INT'L, INC. CARDIOTOMY RESERVOIR W/20 MICRON FILITER 05/13/1993
K070605 MAQUET CARDIOPULMONARY AG JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING 01/04/2008
K141432 MAQUET CARDIOPULMONARY AG NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH 07/07/2014
K102919 MAQUET CARDIOPULMONARY AG NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE 03/11/2011
K090534 MAQUET CARDIOPULMONARY AG VENOUS HARDSHELL CARDIOTOMY RESERVIORS 12/23/2009
K061743 MAQUET CARDIOPULMONARY AG VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001 07/21/2006
K132166 MAQUET CARDIOPULMONARY AG VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT 10/30/2013
K090690 MAQUET CARDIOPULMONARY AG VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING 12/23/2009
K122914 MEDTRONIC INC. AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE 01/09/2013
K031700 MEDTRONIC PERFUSION SYSTEMS MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711 08/29/2003
K021287 MEDTRONIC PERFUSION SYSTEMS TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT 05/07/2002
K903632 MEDTRONIC VASCULAR INTERSEPT 1375 VENOUS RESERVOIR 12/17/1990
K961836 MEDTRONIC VASCULAR MAXIMA FORTE HARDSHELL VENOUS RESERVOIR 11/01/1996
K911790 MEDTRONIC VASCULAR MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG 08/12/1991
K920774 MEDTRONIC VASCULAR MVR COLLAPSIBLE VENOUS RESERVOIR BAG 10/19/1992
K011864 MEDTRONIC VASCULAR TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B 07/09/2001
K151110 Medtronic, Inc Intersept Filtered Cardiotomy Reservoir 05/27/2015
K132972 MEDTRONIC, INC. AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE 10/28/2013
K141233 MEDTRONIC, INC. AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE 06/12/2014
K170583 Medtronic, Inc. Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface 03/17/2017
K953821 MINNTECH CORP. BIOCOR 200 HARDSHELL VENOUS RESERVIOR 03/07/1996
K972017 MINNTECH CORP. BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR) 09/10/1997
K843595 OMNIS SURGICAL, INC. CARDIOTOMY RESERVOIR W/FILTER 02/14/1985
K002496 PACE MEDICAL MODEL 4815 ADAPTER 10/10/2000
K022281 POLYSTAN A/S SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045 08/06/2002
K893705 POLYSTAN C/O VITALCOR, INC. SAFE-1 VENOUS RESERVOIR 12/22/1989
K982136 SCHIFF & CO. JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200 03/24/1999
K813268 SCIMED LIFE SYSTEMS, INC. SC-2500F CARDIOTOMY RESERVIOR 05/18/1982
K882380 SCIMED LIFE SYSTEMS, INC. SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR 10/06/1988
K882720 SCIMED LIFE SYSTEMS, INC. SCIMED R30 SILICONE ASSIST RESERVOIR 09/16/1988
K770036 SHILEY, INC. CARDIOTOMY RESERVOIR 01/14/1977
K884872 SHILEY, INC. DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR 01/30/1989
K893711 SHILEY, INC. DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR 02/28/1990
K872722 SHILEY, INC. EXPANDED USE FOR SHILEY 3L CARDF PLUS 09/23/1987
K872721 SHILEY, INC. EXPANDED USE FOR SHILEY 3L CARDIOTOMY RESERVOIR 09/23/1987
K872719 SHILEY, INC. EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER 09/30/1987
K842711 SHILEY, INC. SHILEY CARDIOTOMY RESERVOIR W/FILTER 08/10/1984
K843232 SHILEY, INC. SHILEY HARDSHELL VENOUS RESERVOIR W/INT 01/14/1985
K911876 SHILEY, INC. SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200 08/09/1991
K872720 SHILEY, INC. SHILEY PTS CHEST DRAINAGE AUTOTRANSFUSION SET 09/23/1987
K802119 SHILEY, INC. SHILEY UTILITY RESERVOIR 09/16/1980
K842337 SHILEY, INC. SHILEY VENOUS RESERVOIR 08/17/1984
K854841 SHILEY, INC. SHILEY VENOUS RESERVOIR 02/10/1986
K832924 SHILEY, INC. VENOUS RESERVOIR 10/31/1983
K945065 SORIN BIOMEDICAL, INC. DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063 05/19/1995
K934847 SORIN BIOMEDICAL, INC. NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS 04/15/1994
K936183 SORIN BIOMEDICAL, INC. SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS 03/23/1994
K934763 SORIN BIOMEDICAL, INC. SORIN BLOOD CARDIOPLEGIA SYSTEM 04/15/1994
K933481 SORIN BIOMEDICAL, INC. SORIN MONOLYTH VENOUS RESERVOIR 11/02/1993
K941215 SORIN BIOMEDICAL, INC. VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR 05/10/1995
K964907 SORIN BIOMEDICAL, INC. VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT 08/21/1997
K964908 SORIN BIOMEDICAL, INC. VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER 09/03/1997
K161733 Sorin Group Italia S.r.l INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C 03/08/2017
K100507 SORIN GROUP ITALIA S.R.L XRES BLOOD COLLECTION RESERVOIR 03/24/2010
K112771 SORIN GROUP ITALIA S.R.L. BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG 10/14/2011
K061527 SORIN GROUP ITALIA S.R.L. CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING 06/27/2006
K092315 SORIN GROUP ITALIA S.R.L. SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR 08/12/2009
K131103 SORIN GROUP ITALIA S.R.L. XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR 06/06/2013
K040023 TERUMO CARDIOVASCULAR SYSTEMS CORP. CAPIOX FLEXIBLE VENOUS RESERVOIR 03/01/2004
K013526 TERUMO CARDIOVASCULAR SYSTEMS CORP. CAPIOX RX HARDSHELL RESERVOIR 11/15/2001
K002238 TERUMO CARDIOVASCULAR SYSTEMS CORP. CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING 08/22/2000
K070839 TERUMO CARDIOVASCULAR SYSTEMS CORP. MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR 04/24/2007
K153143 Terumo Cardiovascular Systems Corporation Capiox Advance Hardshell Reservoir 12/02/2015
K033800 Terumo Cardiovascular Systems Corporation CAPIOX CARDIOTOMY RESERVOIR 02/10/2004
K030449 TERUMO CORP. MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR 03/05/2003
K894664 TERUMO MEDICAL CORP. CAPIOX HARDSHELL VENOUS RESERVOIR 04/20/1990
K980935 TERUMO MEDICAL CORP. CAPIOX SX HARDSHELL RESERVOIR 05/14/1998
K982223 TERUMO MEDICAL CORP. CAPIOX SX HARDSHELL RESEVOIR 09/10/1998
K991973 TERUMO MEDICAL CORP. CAPIOX SX10 HARDSHELL RESEVOIR 09/03/1999
K890077 THE TRAUMAFUSE CO. TRAUMAFUSE RAPID INFUSION DEVICE 04/03/1989
K780517 TRAVENOL LABORATORIES, S.A. CARDIOTOMY RESERVOIR 04/13/1978
K760823 TRAVENOL LABORATORIES, S.A. TMO OXYGENATOR RESERVOIR PUMP SET 11/12/1976


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