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 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 Mar 05, 2008
CAPIOX CIRCUIT CONNECTORS
K073474
Terumo Corp.
Cardiovascular · 85d
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
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

About Product Code DTL - Regulatory Context