Panels › Cardiovascular › Product code DTL · Class 2
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Regulation 870.4290
0510(k)s in 12 months (137 all time)
5recalls in 12 months (59 all time)
46recalls that name a 510(k)
Top companies in DTL
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 2, 2015 | K152528 | Attachable Cath Lab Hemostasis Valve Galt Medical Corp. | DTL |
| Dec 22, 2014 | K143429 | Passage Hemostasis Valve Merit Medical Systems, Inc., IE | DTL |
| Apr 16, 2014 | K140475 | ROTATING ADAPTERS Merit Medical Systems, Inc. | DTL |
| Aug 28, 2013 | K131124 | COLIGN Jilin Coronado Medical , Ltd., CN | DTL |
| Dec 13, 2012 | K123448 | AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE Medtronic, Inc. | DTL |
| Oct 12, 2012 | K122811 | CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE Medtronic, Inc. | DTL |
| Sep 7, 2012 | K122301 | GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE Vascular Solutions Zerusa , Ltd. | DTL |
| Apr 3, 2012 | K120069 | MEDLINE STOPCOCK AND MANIFOLD Medline Industries, Inc. | DTL |
| Feb 28, 2012 | K113148 | E-PASS Synexmed(Shenzhen)Company Limited, CN | DTL |
| Jan 25, 2012 | K113845 | TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE Medtronic, Inc. | DTL |
| Jan 20, 2012 | K113132 | DISPOSABLE HEMOSTATIC Y-CONNECTORS Coeur, Inc. | DTL |
| Jan 12, 2012 | K113667 | CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING Edwards Lifesciences, LLC | DTL |
| May 21, 2010 | K101113 | GUARDIAN II NC HEMOSTASIS VALVE Zerusa Limited, IE | DTL |
| May 19, 2010 | K093992 | TERUMO LAUER LOCK ADAPTER Terumo Cardiovascular Systems Corporation | DTL |
| Apr 28, 2010 | K100319 | MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L Merit Medical Systems, Inc. | DTL |
| Mar 1, 2010 | K091634 | NMI FC Navilyst Medical, Inc. | DTL |
| Nov 4, 2009 | K092563 | GATOR CLIPSEAL PLUG Vascular Solutions, Inc. | DTL |
| Oct 1, 2009 | K092711 | GUARDIAN II HEMOSTASIS VALVE Zerusa Limited, IE | DTL |
| Apr 23, 2008 | K080472 | SEDAT MYSHELL LITE Sedat | DTL |
| Mar 13, 2008 | K073260 | LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109 Device Partners International | DTL |
| Mar 5, 2008 | K073474 | CAPIOX CIRCUIT CONNECTORS Terumo Corp. | DTL |
| Feb 27, 2008 | K073620 | GUARDIAN HEMOSTASIS VALVE Zerusa Limited, IE | DTL |
| Jan 4, 2008 | K072745 | Y-GLIDE Thomas Medical Products, Inc. | DTL |
| Nov 20, 2007 | K072556 | HEMOSTASIS VALVE Merit Medical Systems, Inc. | DTL |
| Jun 29, 2006 | K060759 | Y-CLICK CONNECTOR Elcam Medical Acal, IL | DTL |
| Jan 11, 2006 | K052459 | 6248VAL ADJUSTABLE VALVE Medtronic Vascular | DTL |
| Nov 21, 2005 | K052381 | GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER Zerusa Limited, IE | DTL |
| Oct 6, 2004 | K042060 | EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE Millimed A/S | DTL |
| Aug 11, 2004 | K041697 | TERUMO CIRCUIT CONNECTORS Terumo Cardiovascular Systems Corporation | DTL |
| Jul 2, 2004 | K040498 | MYSHELL Sedat S.A. | DTL |
| Jan 16, 2004 | K033328 | NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT Novosci Corp. | DTL |
| Jul 2, 2003 | K031688 | RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE Guidant Corporation | DTL |
| May 20, 2003 | K031398 | IS-1 HEMOSTASIS VALVE, MODEL 6799 Guidant Corp. | DTL |
| Mar 14, 2003 | K030077 | GISH TUBING AND CONNECTORS WITH GBS COATING Gish Biomedical, Inc. | DTL |
| Nov 27, 2002 | K022918 | ADAPTERS WITH X-COATING Terumo Cardiovascular Systems Corporation | DTL |
| May 2, 2002 | K021282 | LV-1 HEMOSTASIS VALVE, MODEL #6789 Guidant Corp. | DTL |
| Feb 7, 2001 | K003604 | ADAPTERS WITH X-COATING Terumo Cardiovascular Systems Corp. | DTL |
| Nov 10, 1999 | K992906 | COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT Olson Medical Sales, Inc. | DTL |
| Oct 5, 1999 | K993057 | MBA Merit Medical Systems, Inc. | DTL |
| Jun 9, 1999 | K991102 | COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331 Guidant Corp. | DTL |
| Oct 8, 1997 | K972654 | MANIFOLD Medical Specialties Intl., Inc. | DTL |
| Dec 17, 1996 | K963749 | HIGH PRESSURE INJECTION LINES Maxxim Medical | DTL |
| Jun 21, 1996 | K961181 | NMI VEIN GRAFT PERFUSION SET Naltiac Medical, Inc. | DTL |
| Mar 4, 1996 | K955554 | HEMO-VALVE North American Instrument Corp. | DTL |
| Feb 12, 1996 | K954284 | MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON) Medi-Plast Intl., Inc. | DTL |
| Feb 2, 1996 | K953564 | MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE Medtronic Cardiac Surgery, Medtronic, Inc. | DTL |
| Aug 24, 1995 | K952531 | QUEST VEIN GRAFT PERFUSION SET Quest Medical, Inc. | DTL |
| Jun 21, 1995 | K942391 | BRAUN MANIFOLD B.Braun Medical, Inc. | DTL |
| May 31, 1995 | K951089 | SCIMED GATEWAY PLUS Scimed Life Systems, Inc. | DTL |
| Mar 3, 1995 | K945931 | RMI CIRKUIT-GUARD(TM) PRESSURE RELIEF VALVE Research Industries Corp. | DTL |
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