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
25–48 of 52
Cleared Aug 05, 1997
AFFINITY BLOOD PUMP SYSTEM
K964017
Avecor Cardiovascular, Inc.
Cardiovascular · 302d
Cleared Jan 30, 1996
JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM
K943803
Janus Biomedical, Inc.
Cardiovascular · 544d
Cleared Jan 19, 1996
STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE
K950990
Stoeckert Instrumente
Cardiovascular · 322d
Cleared Jul 08, 1992
SARNS 8000 MODULAR PERFUSION SYSTEM
K915183
3M Health Care, Sarns
Cardiovascular · 233d
Cleared May 21, 1987
SARNS 9000 HEART-LUNG CONSOLE
K871131
3M Health Care, Sarns
Cardiovascular · 62d
Cleared May 06, 1987
ONGUARD 1000, CATALOG #043611-000 & 043611-001
K870976
Cobe Laboratories, Inc.
Cardiovascular · 57d
Cleared Dec 11, 1986
STOCKERT-SHILEY CAPS BATTERY MODULE
K863960
Shiley, Inc.
Cardiovascular · 62d
Cleared Nov 18, 1986
STOCKERT-SHILEY CAPS HLM INTERFACE
K863541
Shiley, Inc.
Cardiovascular · 68d
Cleared Oct 01, 1986
STOCKERT-SHILEY CAPS TIMER MODULE
K862973
Shiley, Inc.
Cardiovascular · 56d
Cleared Jun 23, 1986
SARNS PORTABLE POWER MODULE
K861388
3M Health Care, Sarns
Cardiovascular · 70d
Cleared Aug 03, 1984
COBE EMERGENCY POWER SOURCE 43610-000
K842138
Cobe Laboratories, Inc.
Cardiovascular · 65d
Cleared Aug 24, 1982
GAMBRO PUMP CONSOLE CSL
K822068
Gambro, Inc.
Cardiovascular · 41d
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