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 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 Dec 11, 2003
SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800
K033641
Cobe Cardiovascular, Inc.
Cardiovascular · 21d
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 Nov 15, 2001
CAPIOX RX HARDSHELL RESERVOIR
K013526
Terumo Cardiovascular Systems Corp.
Cardiovascular · 23d
Cleared Jul 09, 2001
TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B
K011864
Medtronic Vascular
Cardiovascular · 25d
Cleared Aug 22, 2000
CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING
K002238
Terumo Cardiovascular Systems Corp.
Cardiovascular · 29d
Cleared Mar 27, 2000
COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED
K994389
Cobe Cardiovascular, Inc.
Cardiovascular · 90d
Cleared Dec 03, 1999
COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED
K993001
Cobe Cardiovascular, Inc.
Cardiovascular · 87d
Cleared Sep 03, 1999
CAPIOX SX10 HARDSHELL RESEVOIR
K991973
Terumo Medical Corp.
Cardiovascular · 84d
Cleared May 25, 1999
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K990239
Cobe Cardiovascular, Inc.
Cardiovascular · 120d
Cleared Jan 11, 1999
COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K984456
Cobe Cardiovascular, Inc.
Cardiovascular · 27d
Cleared Sep 10, 1998
CAPIOX SX HARDSHELL RESEVOIR
K982223
Terumo Medical Corp.
Cardiovascular · 78d
Cleared Aug 24, 1998
COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 1800
K980786
Cobe Cardiovascular, Inc.
Cardiovascular · 175d
Cleared Aug 05, 1998
BARD QUANTUM SVR MODEL NUMBER H-6440VR
K981628
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared May 14, 1998
CAPIOX SX HARDSHELL RESERVOIR
K980935
Terumo Medical Corp.
Cardiovascular · 63d
Cleared Jan 22, 1998
BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT
K974155
Baxter Healthcare Corp
Cardiovascular · 79d
Cleared Jul 23, 1997
COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR
K971669
Cobe Cardiovascular, Inc.
Cardiovascular · 78d