DTL · Class II · 21 CFR 870.4290

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

Leading manufacturers include Merit Medical Systems, Inc., Dlp, Inc. and C.R. Bard, Inc..

137
Total
137
Cleared
94d
Avg days
1976
Since

FDA 510(k) Cleared Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Devices (Product Code DTL)

137 devices
1–24 of 137
Cleared Dec 22, 2014
Passage Hemostasis Valve
K143429
Merit Medical Systems, Inc.
Cardiovascular · 21d
Cleared Apr 16, 2014
ROTATING ADAPTERS
K140475
Merit Medical Systems, Inc.
Cardiovascular · 49d
Cleared Dec 13, 2012
AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE
K123448
Medtronic, Inc.
Cardiovascular · 35d
Cleared Oct 12, 2012
CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE
K122811
Medtronic, Inc.
Cardiovascular · 29d
Cleared Apr 03, 2012
MEDLINE STOPCOCK AND MANIFOLD
K120069
Medline Industries, Inc.
Cardiovascular · 85d
Cleared Jan 25, 2012
TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE
K113845
Medtronic, Inc.
Cardiovascular · 28d
Cleared Jan 12, 2012
CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING
K113667
Edwards Lifesciences, LLC
Cardiovascular · 30d
Cleared Apr 28, 2010
MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R
K100319
Merit Medical Systems, Inc.
Cardiovascular · 83d
Cleared Mar 01, 2010
NMI FC
K091634
Navilyst Medical, Inc.
Cardiovascular · 270d
Cleared Nov 04, 2009
GATOR CLIPSEAL PLUG
K092563
Vascular Solutions, Inc.
Cardiovascular · 76d
Cleared Nov 20, 2007
HEMOSTASIS VALVE
K072556
Merit Medical Systems, Inc.
Cardiovascular · 71d
Cleared Jan 11, 2006
6248VAL ADJUSTABLE VALVE
K052459
Medtronic Vascular
Cardiovascular · 126d
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 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 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 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 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

About Product Code DTL - Regulatory Context