FDA 510(k) Applications for Medical Device Product Code "DTL"
(Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)

FDA 510(k) Number Applicant Device Name Decision Date
K893683 3M COMPANY SARNS PRESSURE ADJUSTABLE SAFETY SYSTEM 08/03/1989
K791914 ABBOTT LABORATORIES 3-WAY STOPCOCK W/MALE LOCKING LUER ADA. 10/11/1979
K897197 ADVANCE MEDICAL DESIGNS, INC. ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI. 03/19/1990
K911884 ADVANCE MEDICAL DESIGNS, INC. ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINES 07/05/1994
K915301 ADVANCE MEDICAL DESIGNS, INC. ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK 12/11/1992
K897196 ADVANCE MEDICAL DESIGNS, INC. ADVANCE STOPCOCKS ADVANCE MANIFOLDS 03/27/1990
K854261 ADVANCED CARDIOVASCULAR SYSTEMS, INC. ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES 12/04/1985
K853950 AMERICAN BENTLEY ARTERIAL/VENOUS SAMPLE LINE BOS-CMSL 12/11/1985
K873488 AMERICAN OMNI MEDICAL, INC. SILENT GUARD CAT. NO. SG-10 10/07/1987
K851465 AMERICAN OMNI MEDICAL, INC. SILENT GUARD CAT. NO. SG-30 08/05/1985
K840797 AMERICAN PHARMASEAL DIV. AHSC MALE-MALE LUER LOCK CONNECTOR W/ROTA 04/24/1984
K942391 B. BRAUN MEDICAL, INC. BRAUN MANIFOLD 06/21/1995
K883956 BIO MEDICUS, INC. BIO-MEDICUS TUBING CONNECTORS 10/28/1988
K860291 BIOMEDICAL EXPORTS, INC. TUBING CONNECTORS 03/31/1986
K780056 C.R. BARD, INC. OXYGENATOR HOLDER 02/01/1978
K801200 C.R. BARD, INC. SAMPLING MANIFOLD H530 06/04/1980
K884200 C.R. BARD, INC. USCI TANDEM ADAPTER 12/05/1988
K820297 C.R. BARD, INC. WM. HARVEY OVERPRESSURE SAFETY VALVE 03/12/1982
K870325 CLINICAL CONNECTIONS, INC. #014160-TAB TUBING ROTATOR ADAPTOR 04/27/1987
K870073 CLINICAL CONNECTIONS, INC. MANIFOLD SWIVEL ROTATOR MODELS 014320 & 014321-TAB 02/20/1987
K780271 COBE LABORATORIES, INC. COBE STOPCOCK 03/02/1978
K781579 COBE LABORATORIES, INC. MODIFIED STERILE DISPOSABLE STOPCOCKS 10/05/1978
K113132 COEUR, INC. DISPOSABLE HEMOSTATIC Y-CONNECTORS 01/20/2012
K792113 CONPHAR, INC. CONPHAR MANOMETER CONNECTORS 12/05/1979
K863177 CORDIS CORP. CORDIS ANGIOPLASTY HEMOSTASIS DEVICES 10/15/1986
K073260 DEVICE PARTNERS INTERNATIONAL LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109 03/13/2008
K790564 DLP, INC. ADAPTER-STRAIGHT 04/12/1979
K791498 DLP, INC. ADAPTER-Y TYPE/CORONARY PERFUSION 08/28/1979
K790563 DLP, INC. ADAPTERS-Y-TYPE 04/12/1979
K900994 DLP, INC. ANTEGRADE/RETROGRADE "Y" W/INTEGRAL SELECTOR SWIT. 08/15/1990
K853586 DLP, INC. PRESSURE SENSING SYRINGE 65000 11/14/1985
K914987 E-Z-EM, INC. HIGH PRESSURE CONNECTING SETS, MODIFICATION 05/20/1992
K113667 EDWARDS LIFESCIENCES, LLC. CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING 01/12/2012
K060759 ELCAM MEDICAL ACAL Y-CLICK CONNECTOR 06/29/2006
K813141 EXCO, INC. VYGON STOPCOCKS & RAMPS(MANIFOLDS) 11/27/1981
K912969 FREEDOM MACHINE, INC. TORQUE FITTING 11/05/1991
K152528 GALT MEDICAL CORP. Attachable Cath Lab Hemostasis Valve 12/02/2015
K922840 GISH BIOMEDICAL, INC. ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS 05/17/1993
K833644 GISH BIOMEDICAL, INC. FILTER PURGE LINE EC-FPL SERIES 12/29/1984
K030077 GISH BIOMEDICAL, INC. GISH TUBING AND CONNECTORS WITH GBS COATING 03/14/2003
K833322 GISH BIOMEDICAL, INC. TUBING CONNECTORS EC-2XXX SERIES 12/16/1983
K801828 GRAPHIC CONTROLS CORP. MEDI-TRACE DISP. STOPCOCKS/PHYSIO. PRESS 08/27/1980
K991102 GUIDANT CORP. COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331 06/09/1999
K031398 GUIDANT CORP. IS-1 HEMOSTASIS VALVE, MODEL 6799 05/20/2003
K021282 GUIDANT CORP. LV-1 HEMOSTASIS VALVE, MODEL #6789 05/02/2002
K031688 GUIDANT CORPORATION RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE 07/02/2003
K800880 HARVARD LABORATORIES PLASTIC TUBING ADAPTERS 5-IN-1- 05/14/1980
K862451 HEWLETT-PACKARD CO. LUER LOCK SKIRT 10/31/1986
K895795 HPD MEDICAL, INC. HPD TUBING CONNECTORS 01/26/1990
K880831 INTERVENTIONAL MEDICAL, INC. LARGE LUMEN "Y" ADAPTER W/ROTATING DEVICE 05/10/1988
K910845 INTERVENTIONAL THERAPEUTICS CORP. ITC ROTATING HEMOSTATIC VALVE CAT. NO. MX 1012 05/21/1991
K131124 JILIN CORONADO MEDICAL LTD. COLIGN 08/28/2013
K913363 KROY MEDICAL, INC. CUSTOM TUBING PACKS 12/20/1991
K890676 L.O.N. RESEARCH, INC. DISPOSABLE TRANSDUCER MANIFOLD 07/14/1989
K812408 L.O.N. RESEARCH, INC. L.O.N. DISPOSABLE CORONARY MANIFOLD 12/02/1981
K853099 L.O.N. RESEARCH, INC. L.O.N. PRES MON LINES, CPC LINES, ADMINISTRATION 12/03/1985
K812407 L.O.N. RESEARCH, INC. L.O.N. REUSABLE MANIFOLDS & STOPCOCKS 12/02/1981
K963749 MAXXIM MEDICAL HIGH PRESSURE INJECTION LINES 12/17/1996
K912709 MEDEX, INC. MX 339 TWIN HEMOSTATIC Y CONNECTOR 09/11/1991
K954284 MEDI-PLAST INTL., INC. MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON) 02/12/1996
K863402 MEDI-PLAST INTL., INC. MEDI-PLAST DISPOSABLE MANIFOLD 10/22/1986
K863661 MEDICAL COMPONENTS, INC. MEDCOMP DISPOSABLE MANIFOLD SYSTEM 09/29/1986
K972654 MEDICAL SPECIALTIES INTL., INC. MANIFOLD 10/08/1997
K791797 MEDICAL TESTING SYSTEM, INC. MTS CATHETER ADAPTER FOR GUIDANCE ENTRY 10/11/1979
K120069 MEDLINE INDUSTRIES, INC. MEDLINE STOPCOCK AND MANIFOLD 04/03/2012
K953564 MEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC. MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE 02/02/1996
K123448 MEDTRONIC INC. AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE 12/13/2012
K122811 MEDTRONIC INC. CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE 10/12/2012
K113845 MEDTRONIC INC. TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE 01/25/2012
K052459 MEDTRONIC VASCULAR 6248VAL ADJUSTABLE VALVE 01/11/2006
K945461 MEDTRONICS INTERVENTIONAL VASCULAR PITON(TM) Y-PACK AND PITON(TM) TRI-PACK) 02/03/1995
K933084 MERIT MEDICAL SYSTEMS, INC. CHECK VALVE (FITTING) 03/23/1994
K072556 MERIT MEDICAL SYSTEMS, INC. HEMOSTASIS VALVE 11/20/2007
K993057 MERIT MEDICAL SYSTEMS, INC. MBA 10/05/1999
K100319 MERIT MEDICAL SYSTEMS, INC. MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L 04/28/2010
K925419 MERIT MEDICAL SYSTEMS, INC. PASSAGE HEMOSTASIS VALVE 01/22/1993
K143429 MERIT MEDICAL SYSTEMS, INC. Passage Hemostasis Valve 12/22/2014
K140475 MERIT MEDICAL SYSTEMS, INC. ROTATING ADAPTERS 04/16/2014
K934123 MERIT MEDICAL SYSTEMS, INC. STOPCOCK (ONE-PORT MANIFOLD) 11/23/1993
K042060 MILLIMED A/S EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE 10/06/2004
K961181 NALTIAC MEDICAL, INC. NMI VEIN GRAFT PERFUSION SET 06/21/1996
K091634 NAVILYST MEDICAL, INC. NMI FC 03/01/2010
K955554 NORTH AMERICAN INSTRUMENT CORP. HEMO-VALVE 03/04/1996
K842829 NORTH AMERICAN INSTRUMENT CORP. HIGH PRESSURE, 1 & 3 WAY STERILE DISPOS 10/18/1984
K890580 NORTH AMERICAN INSTRUMENT CORP. LIPID STOPCOCK 04/19/1989
K884408 NORTH AMERICAN INSTRUMENT CORP. NAMIC DUAL BACKCHECK VALVE 01/12/1989
K900652 NORTH AMERICAN INSTRUMENT CORP. NAMIC PTCA Y-ADAPTOR 06/26/1990
K820864 NORTON PERFORMANCE PLASTICS CORP. NORTON MANIFOLD 04/15/1982
K791107 NORTON PERFORMANCE PLASTICS CORP. STOPCOCK, THREE WAY 06/22/1979
K033328 NOVOSCI CORP. NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT 01/16/2004
K992906 OLSON MEDICAL SALES, INC. COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT 11/10/1999
K852118 OMSER SV., INC. MANIFOLD CLAMPS 06/06/1985
K891572 PROCEDURE PACKS, INC. ANGIOGRAPHY CUSTOM PACKS 07/24/1989
K882717 PROCEDURE PACKS, INC. PROCEDURE PACKS CONTRAST MEDIA SETS 12/28/1988
K853749 PROCEDURE PRODUCTS, INC. CUSTOM CORONARY MANIFOLD KITS 01/13/1986
K952531 QUEST MEDICAL, INC. QUEST VEIN GRAFT PERFUSION SET 08/24/1995
K945931 RESEARCH INDUSTRIES CORP. RMI CIRKUIT-GUARD(TM) PRESSURE RELIEF VALVE 03/03/1995
K892377 RESEARCH MEDICAL, INC. RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SET 12/07/1989
K897137 RESEARCH MEDICAL, INC. RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING 03/27/1990
K892368 RESEARCH MEDICAL, INC. RMI CARDIOPLEGIA DELIVERY SETS 12/07/1989
K831260 SCIMED LIFE SYSTEMS, INC. SCI MED TEMPERATURE MONITORING ADAPTOR 06/03/1983
K831261 SCIMED LIFE SYSTEMS, INC. SCI MED TUBING CONNECTORS 06/03/1983
K951089 SCIMED LIFE SYSTEMS, INC. SCIMED GATEWAY PLUS 05/31/1995
K080472 SEDAT SEDAT MYSHELL LITE 04/23/2008
K040498 SEDAT S.A. MYSHELL 07/02/2004
K170024 SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD. Y-Connector Kit 10/03/2017
K840603 SHILEY, INC. ARTERIAL FILTER PURGE LINE W/CHECK VALV 04/19/1984
K872161 SHILEY, INC. DIDECO-SHILEY PREASSEMBLED SURGICAL WASH SET 08/12/1987
K790804 SURGIKOS, INC. PURGE LINE UNIT 05/25/1979
K113148 SYNEXMED(SHENZHEN)COMPANY LIMITED E-PASS 02/28/2012
K854397 TARGET THERAPEUTICS HEMOSTATIC SIDEARM 01/08/1986
K873971 TARGET THERAPEUTICS ROTATING HEMOSTATIC VALVE 01/19/1988
K003604 TERUMO CARDIOVASCULAR SYSTEMS CORP. ADAPTERS WITH X-COATING 02/07/2001
K022918 Terumo Cardiovascular Systems Corporation ADAPTERS WITH X-COATING 11/27/2002
K041697 Terumo Cardiovascular Systems Corporation TERUMO CIRCUIT CONNECTORS 08/11/2004
K093992 Terumo Cardiovascular Systems Corporation TERUMO LAUER LOCK ADAPTER 05/19/2010
K073474 TERUMO CORP. CAPIOX CIRCUIT CONNECTORS 03/05/2008
K852086 TERUMO MEDICAL CORP. CAPIOX BLOOD SAMPLING MANIFOLD 08/09/1985
K801399 TEXAS MEDICAL PRODUCTS, INC. CORONARY PERFUSION CONNECTOR PLUG 06/30/1980
K801404 TEXAS MEDICAL PRODUCTS, INC. DISPOSABLE PARALLEL "Y" CONNECTORS 06/30/1980
K801405 TEXAS MEDICAL PRODUCTS, INC. DISPOSABLE PERFUSION CONNECTORS 06/30/1980
K802544 TEXAS MEDICAL PRODUCTS, INC. DISPOSABLE QUICK RELEASE PERFUSION ADAP 01/16/1981
K801402 TEXAS MEDICAL PRODUCTS, INC. QUICKIE PRIME CARDIOP. BYPASS PERF. INTR 06/30/1980
K072745 THOMAS MEDICAL PRODUCTS, INC. Y-GLIDE 01/04/2008
K832625 TOP SURGICAL MANUFACTURERS CO. TOP THREE WAY STOPCOCK 10/19/1983
K772299 UNI-RESEARCH TRANSPARENT MANIFOLD 12/21/1977
K760843 USCI, DIV. C.R. BARD, INC. PALEY TRANSPARENT MANIFOLD 11/12/1976
K854960 UTAH MEDICAL PRODUCTS, INC. DISPOSABLE MANIFOLD 02/10/1986
K861783 UTAH MEDICAL PRODUCTS, INC. DISPOSABLE STOPCOCK 07/17/1986
K122301 VASCULAR SOLUTIONS ZERUSA LTD. GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE 09/07/2012
K092563 VASCULAR SOLUTIONS, INC. GATOR CLIPSEAL PLUG 11/04/2009
K902741 VASCUMED SYSTEMS VASCUMED EZ Y-CONNECTOR 11/01/1990
K073620 ZERUSA LIMITED GUARDIAN HEMOSTASIS VALVE 02/27/2008
K052381 ZERUSA LIMITED GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER 11/21/2005
K092711 ZERUSA LIMITED GUARDIAN II HEMOSTASIS VALVE 10/01/2009
K101113 ZERUSA LIMITED GUARDIAN II NC HEMOSTASIS VALVE 05/21/2010


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