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 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
Cleared May 31, 1995
SCIMED GATEWAY PLUS
K951089
Scimed Life Systems, Inc.
Cardiovascular · 83d
Cleared Feb 03, 1995
PITON(TM) Y-PACK AND PITON(TM) TRI-PACK)
K945461
Medtronics Interventional Vascular
Cardiovascular · 88d
Cleared Jul 05, 1994
ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINES
K911884
Advance Medical Designs, Inc.
Cardiovascular · 1163d
Cleared Mar 23, 1994
CHECK VALVE (FITTING)
K933084
Merit Medical Systems, Inc.
Cardiovascular · 273d
Cleared Nov 23, 1993
STOPCOCK (ONE-PORT MANIFOLD)
K934123
Merit Medical Systems, Inc.
Cardiovascular · 90d
Cleared May 17, 1993
ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS
K922840
Gish Biomedical, Inc.
Cardiovascular · 339d
Cleared Jan 22, 1993
PASSAGE HEMOSTASIS VALVE
K925419
Merit Medical Systems, Inc.
Cardiovascular · 87d
Cleared Dec 11, 1992
ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK
K915301
Advance Medical Designs, Inc.
Cardiovascular · 386d