DTP · Class II · 21 CFR 870.4230

FDA Product Code DTP: Defoamer, Cardiopulmonary Bypass

Leading manufacturers include Medtronic Vascular, Shiley, Inc. and Scimed Life Systems, Inc..

34
Total
34
Cleared
81d
Avg days
1980
Since

FDA 510(k) Cleared Defoamer, Cardiopulmonary Bypass Devices (Product Code DTP)

34 devices
1–24 of 34
Cleared Apr 26, 2001
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K004046
Cobe Cardiovascular, Inc.
Cardiovascular · 118d
Cleared Sep 13, 2000
COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K002591
Cobe Cardiovascular, Inc.
Cardiovascular · 23d
Cleared Mar 09, 1999
MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR
K990514
C.R. Bard, Inc.
Cardiovascular · 19d
Cleared Oct 30, 1996
BARD QUANTUM CVR
K962726
C.R. Bard, Inc.
Cardiovascular · 107d
Cleared Jul 26, 1994
SARNS FILTERED VENOUS RESERVIOR MODIFICATION
K941654
3M Health Care, Sarns
Cardiovascular · 112d
Cleared Oct 15, 1993
MAXIMA FILTERED HARDSHELL RESERVIOR
K933496
Medtronic Vascular
Cardiovascular · 88d
Cleared Sep 25, 1991
SARNS NON-FILTERED VENOUS RESERVOIR
K912915
3M Health Care, Ltd.
Cardiovascular · 84d
Cleared Aug 20, 1991
MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT
K911789
Medtronic Vascular
Cardiovascular · 120d
Cleared Apr 09, 1991
MODEL 5866-46 SLEEVE KIT
K910568
Medtronic Vascular
Cardiovascular · 57d
Cleared Dec 17, 1990
COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER
K902437
Cobe Laboratories, Inc.
Cardiovascular · 196d
Cleared Sep 27, 1990
BARD FILTERED CARDIOTOMY RESERVOIR
K902856
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared Aug 23, 1990
MCR4000 & MCR4000F CARDIOTOMY RESERVOIR
K902355
Medtronic Vascular
Cardiovascular · 86d
Cleared Jan 19, 1988
CAP-35 AND CAP35 F
K874924
Gish Biomedical, Inc.
Cardiovascular · 48d
Cleared Sep 01, 1987
CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500
K872167
American Bentley
Cardiovascular · 85d
Cleared Apr 28, 1987
THORASTAT ATR-XXXX
K870792
Gish Biomedical, Inc.
Cardiovascular · 61d
Cleared May 28, 1986
SARNS FILTERED CARDIOTOMY RESERVOIR
K860702
3M Health Care, Sarns
Cardiovascular · 92d
Cleared Feb 26, 1986
MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR
K855049
Scimed Life Systems, Inc.
Cardiovascular · 71d
Cleared Nov 14, 1985
SHILEY 3L CARDIOTOMY RESERVOIR
K853503
Shiley, Inc.
Cardiovascular · 85d
Cleared May 16, 1985
CARDIOTOMY RESERVOIR BRS-XXX & HOLDER BRS-HXX
K851004
Gish Biomedical, Inc.
Cardiovascular · 65d
Cleared Apr 29, 1985
POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTE
K844803
Electromedics, Inc.
Cardiovascular · 139d
Cleared Dec 27, 1984
VENOUS RESERVOIR-BMR-1500-HARD SHELL
K842373
American Bentley
Cardiovascular · 195d
Cleared Apr 24, 1984
SCIMED MODEL SC4000
K840610
Scimed Life Systems, Inc.
Cardiovascular · 71d
Cleared Jan 30, 1984
CARDIOTOMY RESERVOIR SC3500F
K834041
Scimed Life Systems, Inc.
Cardiovascular · 68d
Cleared Sep 20, 1983
SHILEY 3L CARDF PLUS
K832811
Shiley, Inc.
Cardiovascular · 33d

About Product Code DTP - Regulatory Context