DTQ · Class II · 21 CFR 870.4220

FDA Product Code DTQ: Console, Heart-lung Machine, Cardiopulmonary Bypass

Leading manufacturers include Sorin Group Deutschland GmbH, Terumo Cardiovascular Systems Corporation and 3M Health Care, Sarns.

52
Total
52
Cleared
125d
Avg days
1977
Since
52 devices
49–52 of 52
Cleared Nov 27, 1981
POLYSTAN HEART LUNG MACHINE SYS
K813034
Advocacy International, Ltd.
Cardiovascular · 30d
Cleared May 20, 1980
SARNS 7000 MONITOR MODULE
K801097
3M Health Care, Sarns
Cardiovascular · 11d
Cleared Nov 02, 1977
SARNES HELP
K772001
3M Health Care, Sarns
Cardiovascular · 12d
Cleared Mar 07, 1977
CONSOLE, MOBILE FOR 3 PUMPS W/MASTS
K770002
Cobe Laboratories, Inc.
Cardiovascular · 63d