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 |