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
K113132 COEUR, INC. DISPOSABLE HEMOSTATIC Y-CONNECTORS 01/20/2012
K073260 DEVICE PARTNERS INTERNATIONAL LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109 03/13/2008
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
K152528 GALT MEDICAL CORP. Attachable Cath Lab Hemostasis Valve 12/02/2015
K030077 GISH BIOMEDICAL, INC. GISH TUBING AND CONNECTORS WITH GBS COATING 03/14/2003
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
K131124 JILIN CORONADO MEDICAL LTD. COLIGN 08/28/2013
K963749 MAXXIM MEDICAL HIGH PRESSURE INJECTION LINES 12/17/1996
K954284 MEDI-PLAST INTL., INC. MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON) 02/12/1996
K972654 MEDICAL SPECIALTIES INTL., INC. MANIFOLD 10/08/1997
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
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
K143429 MERIT MEDICAL SYSTEMS, INC. Passage Hemostasis Valve 12/22/2014
K140475 MERIT MEDICAL SYSTEMS, INC. ROTATING ADAPTERS 04/16/2014
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
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
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
K113148 SYNEXMED(SHENZHEN)COMPANY LIMITED E-PASS 02/28/2012
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
K072745 THOMAS MEDICAL PRODUCTS, INC. Y-GLIDE 01/04/2008
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
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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