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 Texas Medical Products, 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 02, 2015
Attachable Cath Lab Hemostasis Valve
K152528
Galt Medical Corp.
Cardiovascular · 90d
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 Aug 28, 2013
COLIGN
K131124
Jilin Coronado Medical , Ltd.
Cardiovascular · 128d
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 Sep 07, 2012
GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE
K122301
Vascular Solutions Zerusa , Ltd.
Cardiovascular · 37d
Cleared Apr 03, 2012
MEDLINE STOPCOCK AND MANIFOLD
K120069
Medline Industries, Inc.
Cardiovascular · 85d
Cleared Feb 28, 2012
E-PASS
K113148
Synexmed(Shenzhen)Company Limited
Cardiovascular · 127d
Cleared Jan 25, 2012
TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE
K113845
Medtronic, Inc.
Cardiovascular · 28d
Cleared Jan 20, 2012
DISPOSABLE HEMOSTATIC Y-CONNECTORS
K113132
Coeur, Inc.
Cardiovascular · 88d
Cleared Jan 12, 2012
CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING
K113667
Edwards Lifesciences, LLC
Cardiovascular · 30d
Cleared May 21, 2010
GUARDIAN II NC HEMOSTASIS VALVE
K101113
Zerusa Limited
Cardiovascular · 30d
Cleared May 19, 2010
TERUMO LAUER LOCK ADAPTER
K093992
Terumo Cardiovascular Systems Corporation
Cardiovascular · 146d
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 Oct 01, 2009
GUARDIAN II HEMOSTASIS VALVE
K092711
Zerusa Limited
Cardiovascular · 28d
Cleared Apr 23, 2008
SEDAT MYSHELL LITE
K080472
Sedat
Cardiovascular · 62d
Cleared Mar 13, 2008
LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109
K073260
Device Partners International
Cardiovascular · 114d
Cleared Mar 05, 2008
CAPIOX CIRCUIT CONNECTORS
K073474
Terumo Corp.
Cardiovascular · 85d
Cleared Feb 27, 2008
GUARDIAN HEMOSTASIS VALVE
K073620
Zerusa Limited
Cardiovascular · 63d
Cleared Jan 04, 2008
Y-GLIDE
K072745
Thomas Medical Products, Inc.
Cardiovascular · 99d
Cleared Nov 20, 2007
HEMOSTASIS VALVE
K072556
Merit Medical Systems, Inc.
Cardiovascular · 71d

About Product Code DTL - Regulatory Context