DTN · Class II · 21 CFR 870.4400

FDA Product Code DTN: Reservoir, Blood, Cardiopulmonary Bypass

Leading manufacturers include Gish Biomedical, Inc., Shiley, Inc. and American Bentley.

169
Total
169
Cleared
109d
Avg days
1976
Since
169 devices
25–48 of 169
Cleared Feb 04, 2009
GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING
K082082
Gish Biomedical, Inc.
Cardiovascular · 196d
Cleared Jan 04, 2008
JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING
K070605
Maquet Cardiopulmonary, AG
Cardiovascular · 305d
Cleared Dec 20, 2007
3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES
K072697
3t Medical Systems, LLC
Cardiovascular · 87d
Cleared Apr 24, 2007
MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR
K070839
Terumo Cardiovascular Systems Corp.
Cardiovascular · 28d
Cleared Jul 21, 2006
VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000
K061743
Maquet Cardiopulmonary, AG
Cardiovascular · 30d
Cleared Jun 27, 2006
CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING
K061527
Sorin Group Italia S.R.L.
Cardiovascular · 25d
Cleared Aug 12, 2005
GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING
K051606
Gish Biomedical, Inc.
Cardiovascular · 57d
Cleared Mar 17, 2005
V-BAG WITH GBS COATING
K050195
Gish Biomedical, Inc.
Cardiovascular · 49d
Cleared Mar 08, 2005
SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG
K050111
Cobe Cardiovascular, Inc.
Cardiovascular · 49d
Cleared Mar 01, 2004
CAPIOX FLEXIBLE VENOUS RESERVOIR
K040023
Terumo Cardiovascular Systems Corp.
Cardiovascular · 54d
Cleared Feb 10, 2004
CAPIOX CARDIOTOMY RESERVOIR
K033800
Terumo Cardiovascular Systems Corporation
Cardiovascular · 67d
Cleared Dec 11, 2003
SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800
K033641
Cobe Cardiovascular, Inc.
Cardiovascular · 21d
Cleared Dec 11, 2003
MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING
K033714
Dideco S.P.A.
Cardiovascular · 15d
Cleared Aug 29, 2003
MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711
K031700
Medtronic Perfusion Systems
Cardiovascular · 88d
Cleared Jun 23, 2003
HEMOBAG, MODEL HBBSD2000
K031150
Global Blood Resources, LLC
Cardiovascular · 74d
Cleared May 30, 2003
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING
K030726
Gish Biomedical, Inc.
Cardiovascular · 84d
Cleared Mar 05, 2003
SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING
K024065
Gish Biomedical, Inc.
Cardiovascular · 86d
Cleared Mar 05, 2003
MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR
K030449
Terumo Corp.
Cardiovascular · 22d
Cleared Aug 06, 2002
SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045
K022281
Polystan A/S
Cardiovascular · 22d
Cleared May 07, 2002
TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT
K021287
Medtronic Perfusion Systems
Cardiovascular · 14d
Cleared Nov 15, 2001
CAPIOX RX HARDSHELL RESERVOIR
K013526
Terumo Cardiovascular Systems Corp.
Cardiovascular · 23d
Cleared Nov 05, 2001
THE V BAG, CATALOG NUMBER VB1800
K012942
Circulatory Technology, Inc.
Cardiovascular · 66d
Cleared Jul 11, 2001
VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201
K003551
Jostra AG
Cardiovascular · 236d
Cleared Jul 09, 2001
TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B
K011864
Medtronic Vascular
Cardiovascular · 25d