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 Mar 15, 2006
MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB
K052555
Rand S.R.L.
Cardiovascular · 180d
Cleared Mar 20, 2003
ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH
K022947
Terumo Cardiovascular Systems Corp.
Cardiovascular · 196d
Cleared Feb 26, 2003
MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100
K030141
Cardiovention, Inc.
Cardiovascular · 42d
Cleared Jan 08, 2003
CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100
K021694
Cardiovention, Inc.
Cardiovascular · 231d
Cleared Sep 23, 2002
STOCKERT CENTRIFUGAL PUMP CONSOLE
K020571
Stockert Instrumente GmbH
Cardiovascular · 214d
Cleared May 02, 2001
SIII ALARM AMPLIFIER
K011088
Stockert Instrumente GmbH
Cardiovascular · 22d
Cleared Aug 09, 2000
S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0
K002116
Medical Device Consultants, Inc.
Cardiovascular · 27d
Cleared Aug 09, 2000
STOCKERT COMPACT SYSTEM VERSION 2.0
K002118
Stoeckert Instrumente
Cardiovascular · 27d
Cleared Sep 04, 1998
STOCKERT COMPACT SYSTEM
K982014
Stoeckert Instrumente
Cardiovascular · 88d
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 Jan 27, 1995
SORIN BLOOD CARDIOPLEGIA CONSOLE
K942582
Sorin Biomedical, Inc.
Cardiovascular · 240d
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 Jun 19, 1985
CENTRIMED SYSTEM 1 W/24 VOLT BATTERY POWER SUPPLY
K851614
Centrimed Corp.
Cardiovascular · 61d
Cleared Jun 19, 1985
CENTRIMED SYSTEM 1 W/MANUAL PUMP DRIVE
K851615
Centrimed Corp.
Cardiovascular · 61d
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