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
49–72 of 169
Cleared Oct 10, 2000
MODEL 4815 ADAPTER
K002496
Pace Medical
Cardiovascular · 57d
Cleared Aug 22, 2000
CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING
K002238
Terumo Cardiovascular Systems Corp.
Cardiovascular · 29d
Cleared Jul 07, 2000
THE V-BAG
K001822
Circulatory Technology, Inc.
Cardiovascular · 21d
Cleared Jun 08, 2000
DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.)
K001602
Dideco S.P.A.
Cardiovascular · 15d
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 Nov 01, 1999
DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR
K992599
Dideco S.P.A.
Cardiovascular · 90d
Cleared Sep 03, 1999
CAPIOX SX10 HARDSHELL RESEVOIR
K991973
Terumo Medical Corp.
Cardiovascular · 84d
Cleared Jun 29, 1999
FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS
K984586
Fresenius Hemotechnology, Inc.
Cardiovascular · 187d
Cleared May 25, 1999
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K990239
Cobe Cardiovascular, Inc.
Cardiovascular · 120d
Cleared Mar 24, 1999
JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200
K982136
Schiff & Co.
Cardiovascular · 280d
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 12, 1998
BETTER-BLADDER (BB)
K981284
Circulatory Technology, Inc.
Cardiovascular · 126d
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 Oct 28, 1997
CHASE TEMPERATURE PROBE
K971013
Chase Medical, Inc.
Cardiovascular · 222d
Cleared Sep 10, 1997
BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR)
K972017
Minntech Corp.
Cardiovascular · 103d
Cleared Sep 03, 1997
VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER
K964908
Sorin Biomedical, Inc.
Cardiovascular · 268d
Cleared Aug 21, 1997
VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT
K964907
Sorin Biomedical, Inc.
Cardiovascular · 255d
Cleared Jul 23, 1997
COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR
K971669
Cobe Cardiovascular, Inc.
Cardiovascular · 78d
Cleared Jul 11, 1997
MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM
K971105
Avecor Cardiovascular, Inc.
Cardiovascular · 107d