DTQ · Class II · 21 CFR 870.4220

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

Leading manufacturers include 3M Health Care, Sarns, Shiley, Inc. and Livanova Deutschland, GmbH.

52
Total
52
Cleared
125d
Avg days
1977
Since
Declining activity - 0 submissions in the last 2 years vs 3 in the prior period

FDA 510(k) Cleared Console, Heart-lung Machine, Cardiopulmonary Bypass Devices (Product Code DTQ)

52 devices
1–24 of 52
Cleared Aug 24, 2023
Essenz HLM, Essenz ILBM
K232291
Livanova Deutschland, GmbH
Cardiovascular · 23d
Cleared Apr 18, 2023
Terumo Advanced Perfusion System 1
K221895
Terumo Cardiovascular Systems Corporation
Cardiovascular · 292d
Cleared Mar 09, 2023
Essenz HLM
K221373
Livanova Deutschland, GmbH
Cardiovascular · 301d
Cleared Apr 05, 2021
Stockert S5 System
K210130
Livanova Deutschland, GmbH
Cardiovascular · 76d
Cleared Mar 07, 2021
Century Perfusion System
K202125
Century Hlm, LLC
Cardiovascular · 219d
Cleared May 24, 2019
Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)
K190282
Spectrum Medical , Ltd.
Cardiovascular · 102d
Cleared May 25, 2018
Quantum Pump Console
K173834
Spectrum Medical , Ltd.
Cardiovascular · 158d
Cleared May 21, 2014
CARDIOHELP SYSTEM
K133598
Maquet Cardiopulmonary, AG
Cardiovascular · 180d
Cleared Feb 20, 2014
ADVANCED PERFUSION SYSTEM 1
K131041
Terumo Cardiovascular Systems Corp.
Cardiovascular · 311d
Cleared Apr 04, 2011
CARDIOHELP SYSTEM
K102726
Maquet Cardiopulmonary, AG
Cardiovascular · 195d
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 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

About Product Code DTQ - Regulatory Context

510(k) Submission Activity

52 total 510(k) submissions under product code DTQ since 1977, with 52 receiving FDA clearance (average review time: 125 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.