DTL · Class II · 21 CFR 870.4290

FDA Product Code DTL: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Leading manufacturers include Merit Medical Systems, Inc., North American Instrument Corp. and Dlp, Inc..

137
Total
137
Cleared
94d
Avg days
1976
Since
137 devices
25–48 of 137
Cleared Jun 29, 2006
Y-CLICK CONNECTOR
K060759
Elcam Medical Acal
Cardiovascular · 100d
Cleared Jan 11, 2006
6248VAL ADJUSTABLE VALVE
K052459
Medtronic Vascular
Cardiovascular · 126d
Cleared Nov 21, 2005
GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER
K052381
Zerusa Limited
Cardiovascular · 83d
Cleared Oct 06, 2004
EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE
K042060
Millimed A/S
Cardiovascular · 68d
Cleared Aug 11, 2004
TERUMO CIRCUIT CONNECTORS
K041697
Terumo Cardiovascular Systems Corporation
Cardiovascular · 50d
Cleared Jul 02, 2004
MYSHELL
K040498
Sedat S.A.
Cardiovascular · 127d
Cleared Jan 16, 2004
NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT
K033328
Novosci Corp.
Cardiovascular · 92d
Cleared Jul 02, 2003
RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE
K031688
Guidant Corporation
Cardiovascular · 30d
Cleared May 20, 2003
IS-1 HEMOSTASIS VALVE, MODEL 6799
K031398
Guidant Corp.
Cardiovascular · 15d
Cleared Mar 14, 2003
GISH TUBING AND CONNECTORS WITH GBS COATING
K030077
Gish Biomedical, Inc.
Cardiovascular · 65d
Cleared Nov 27, 2002
ADAPTERS WITH X-COATING
K022918
Terumo Cardiovascular Systems Corporation
Cardiovascular · 84d
Cleared May 02, 2002
LV-1 HEMOSTASIS VALVE, MODEL #6789
K021282
Guidant Corp.
Cardiovascular · 14d
Cleared Feb 07, 2001
ADAPTERS WITH X-COATING
K003604
Terumo Cardiovascular Systems Corp.
Cardiovascular · 78d
Cleared Nov 10, 1999
COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT
K992906
Olson Medical Sales, Inc.
Cardiovascular · 72d
Cleared Oct 05, 1999
MBA
K993057
Merit Medical Systems, Inc.
Cardiovascular · 22d
Cleared Jun 09, 1999
COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331
K991102
Guidant Corp.
Cardiovascular · 69d
Cleared Oct 08, 1997
MANIFOLD
K972654
Medical Specialties Intl., Inc.
Cardiovascular · 85d
Cleared Dec 17, 1996
HIGH PRESSURE INJECTION LINES
K963749
Maxxim Medical
Cardiovascular · 90d
Cleared Jun 21, 1996
NMI VEIN GRAFT PERFUSION SET
K961181
Naltiac Medical, Inc.
Cardiovascular · 87d
Cleared Mar 04, 1996
HEMO-VALVE
K955554
North American Instrument Corp.
Cardiovascular · 90d
Cleared Feb 12, 1996
MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON)
K954284
Medi-Plast Intl., Inc.
Cardiovascular · 166d
Cleared Feb 02, 1996
MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE
K953564
Medtronic Cardiac Surgery, Medtronic, Inc.
Cardiovascular · 186d
Cleared Aug 24, 1995
QUEST VEIN GRAFT PERFUSION SET
K952531
Quest Medical, Inc.
Cardiovascular · 84d
Cleared Jun 21, 1995
BRAUN MANIFOLD
K942391
B.Braun Medical, Inc.
Cardiovascular · 398d