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
73–91 of 91
Cleared May 09, 1983
BLOOD CARDIOPLEGIA STAINLESS STEEL COOL
K831157
American Bentley
Cardiovascular · 31d
Cleared Jan 14, 1983
CLEAR CARDIOPLEJIA DELIVERY SYSTEM
K823451
3M Health Care, Sarns
Cardiovascular · 58d
Cleared Dec 30, 1982
JACKET & SET
K823533
Shiley, Inc.
Cardiovascular · 31d
Cleared Jul 06, 1982
D6ZO DISPOSABLE HEAT EXCHANGER
K813264
Electromedics, Inc.
Cardiovascular · 228d
Cleared Aug 13, 1981
COBE HEAT EXCHANGER RESERVOIR MODULE
K812093
Cobe Laboratories, Inc.
Cardiovascular · 20d
Cleared May 21, 1981
BRONCHEK-SHILEY CARDIAC JACKET & BSC J
K811204
Shiley, Inc.
Cardiovascular · 20d
Cleared Jan 16, 1981
CARDIOPLEGIC SETS
K802545
Texas Medical Products, Inc.
Cardiovascular · 93d
Cleared Dec 19, 1980
BUCKBERG-SHILEY BLOOD CARDIOPLEGIC SPL.
K802879
Shiley, Inc.
Cardiovascular · 32d
Cleared Dec 11, 1980
CARDIOPLEGIA COOLING SYST. CCAS-2
K802848
Bentley Laboratories, Inc.
Cardiovascular · 29d
Cleared Apr 16, 1980
TOPICAL COOLING DEV. TCD. #27-999
K800717
Cobe Laboratories, Inc.
Cardiovascular · 16d
Cleared Mar 19, 1980
CARDIOPLEGIA DELIVERY SYSTEM
K800377
3M Health Care, Sarns
Cardiovascular · 27d
Cleared Aug 28, 1979
MINIPRIME HYPOTHERMIC HEAT EXCHANGER
K791430
Travenol Laboratories, S.A.
Cardiovascular · 33d
Cleared Jun 11, 1979
HEAT EXCHANGER COIL
K790756
Delta Medical Industries
Cardiovascular · 55d
Cleared Dec 04, 1978
PAD, COOLING #27-999
K781764
Cobe Laboratories, Inc.
Cardiovascular · 49d
Cleared Oct 10, 1978
HEAT EXCHANGER, FHX-14
K781210
Delta Medical Industries
Cardiovascular · 85d
Cleared Mar 02, 1978
HEAT EXCHANGER, DISP., OMNITHERM
K772117
Scimed Life Systems, Inc.
Cardiovascular · 114d
Cleared Jan 14, 1977
PACING KIT, ELECATH TRANSTHORACIC
K770016
Electro-Catheter Corp.
Cardiovascular · 10d
Cleared Jan 14, 1977
PACING KIT, TRANSMYOCARDIAL
K770017
Electro-Catheter Corp.
Cardiovascular · 10d
Cleared Jan 14, 1977
PACING KIT, SEMI-FLOATING
K770018
Electro-Catheter Corp.
Cardiovascular · 10d