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 23, 1999
CAPIOX CARDIOPLEGIA
K982467
Terumo Medical Corp.
Cardiovascular · 343d
Cleared Nov 20, 1997
CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES)
K973475
Medtronic Vascular
Cardiovascular · 69d
Cleared Aug 08, 1997
VISION CARDIOPLEGIA DELIVERY SYSTEM
K964571
Lifestream Int'L, Inc.
Cardiovascular · 267d
Cleared Jan 10, 1997
S3 CARDIOPLEGIA CONTROL
K962320
Stoeckert Instrumente
Cardiovascular · 207d
Cleared Mar 06, 1996
MYOCARDIAL PROTECTION SYSTEM
K953838
Quest Medical, Inc.
Cardiovascular · 203d
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 Mar 26, 1993
BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS
K925369
Sorin Biomedica, Fiat, USA, Inc.
Cardiovascular · 154d
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 Jan 23, 1991
TOPICAL COOLING PAD, MODEL 7000
K905568
Daily Medical Products, Inc.
Cardiovascular · 42d
Cleared Dec 06, 1990
SCIMED CARDIOTHERM CARDIOPLEGIA DELIVERY SYSTEM
K904171
Scimed
Cardiovascular · 86d
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