DTR · Class II · 21 CFR 870.4240

FDA Product Code DTR: Heat-exchanger, Cardiopulmonary Bypass

Leading manufacturers include Shiley, Inc., Gish Biomedical, Inc. and 3M Health Care, Sarns.

91
Total
91
Cleared
112d
Avg days
1977
Since
91 devices
25–48 of 91
Cleared Jun 30, 1995
SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS
K944219
Gish Biomedical, Inc.
Cardiovascular · 305d
Cleared Apr 28, 1995
HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA
K944267
Cobe Cardiovascular, Inc.
Cardiovascular · 239d
Cleared Dec 03, 1993
ELECTROMEDICS BLOOD HEAT EXCHANGER
K934355
Electromedics, Inc.
Cardiovascular · 87d
Cleared Aug 05, 1993
ROTATOR
K932251
Merit Medical Systems, Inc.
Cardiovascular · 87d
Cleared Jul 13, 1993
HE-30 GOLD
K931967
Bentley Laboratories, Inc.
Cardiovascular · 83d
Cleared Sep 18, 1992
CONDUCER HEAT EXCHANGER
K923311
3M Health Care, Sarns
Cardiovascular · 73d
Cleared Jan 09, 1992
LANCASTER COOLING JACKET, CAT. CODE #13500/13501
K913077
Dlp, Inc.
Cardiovascular · 182d
Cleared Dec 18, 1991
CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES
K913691
Gish Biomedical, Inc.
Cardiovascular · 121d
Cleared Dec 04, 1991
MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF
K914742
Medtronic Vascular
Cardiovascular · 84d
Cleared Jun 10, 1991
MYOCARDIAL PROTECTION SYSTEM
K905500
Medtronic Vascular
Cardiovascular · 185d
Cleared Apr 09, 1991
BCD ADVANCED
K910923
Shiley, Inc.
Cardiovascular · 35d
Cleared Jul 31, 1990
SPBC SERIES SINGLE PASS BLOOD CARDIOPLEGIA SYSTEM
K896807
Gish Biomedical, Inc.
Cardiovascular · 239d
Cleared May 17, 1990
EXTRACORPOREAL HEAT EXCHANGER HE SERIES
K896020
Gish Biomedical, Inc.
Cardiovascular · 213d
Cleared Apr 20, 1990
MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDU
K900640
3M Company
Cardiovascular · 70d
Cleared Mar 16, 1990
SARNS MINIPRIME CARDIOPLEGIA SET W/CONDUCER(TM)
K897039
3M Company
Cardiovascular · 88d
Cleared Apr 03, 1989
SCIMED ECMOTHERM(TM) HEAT EXCHANGER
K884560
Scimed Life Systems, Inc.
Cardiovascular · 154d
Cleared Dec 05, 1988
SARNS MP4 CARDIOPLEGIA DELIVERY SYSTEM
K883071
3M Health Care, Sarns
Cardiovascular · 138d
Cleared Sep 26, 1988
BASIC HEATER-COOLER UNIT, 115/100V 16-02-20
K883330
Shiley, Inc.
Cardiovascular · 49d
Cleared Sep 26, 1988
BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10
K883331
Shiley, Inc.
Cardiovascular · 49d
Cleared Sep 26, 1988
MAST FOR BASIC HEATER-COOLER UNIT 16-09-00
K883332
Shiley, Inc.
Cardiovascular · 49d
Cleared May 11, 1988
SHILEY BCD PLUS HEAT EXCHANGER
K880663
Shiley, Inc.
Cardiovascular · 83d
Cleared Apr 28, 1988
SCIMED MODELS P-7-14 AND A-19-38 HEAT EXCHANGERS
K880451
Scimed Life Systems, Inc.
Cardiovascular · 86d
Cleared Nov 05, 1987
ELECTROMEDICS D1079E
K873561
Electromedics, Inc.
Cardiovascular · 64d
Cleared Sep 01, 1987
CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100
K870804
American Bentley
Cardiovascular · 186d