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 Dec 04, 1978
PAD, COOLING #27-999
K781764
Cobe Laboratories, Inc.
Cardiovascular · 49d
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