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
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 Aug 17, 2017
Advanced Perfusion System 1
K172220
Terumo Cardiovascular Systems Corporation
Cardiovascular · 24d
Cleared Jun 07, 2017
Advanced Perfusion System 1
K163531
Terumo Cardiovascular Systems Corporation
Cardiovascular · 173d
Cleared Dec 16, 2015
Advanced Perfusion System 1
K153376
Terumo Cardiovascular Systems Corporation
Cardiovascular · 23d
Cleared Aug 27, 2015
Advanced Perfusion System 1
K151349
Terumo Cardiovascular Systems Corporation
Cardiovascular · 99d
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 Jan 20, 2011
SORIN C5 SYSTEM
K103762
Sorin Group Deutschland GmbH
Cardiovascular · 28d
Cleared Jan 15, 2010
SORIN C5 SYSTEM MODEL 58-00-00
K093882
Sorin Group Deutschland GmbH
Cardiovascular · 28d
Cleared Nov 05, 2009
SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM
K092463
Sorin Group Deutschland GmbH
Cardiovascular · 86d
Cleared Jul 02, 2009
AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05
K091007
Sorin Group Deutschland GmbH
Cardiovascular · 84d
Cleared Jul 30, 2008
STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER
K080832
Sorin Group Deutschland GmbH
Cardiovascular · 127d
Cleared Jul 06, 2007
MODIFICATION TO: STOCKERT S5 SYSTEM
K071318
Sorin Group Deutschland GmbH
Cardiovascular · 57d
Cleared Sep 28, 2006
MODIFICATION TO STOCKERT S5 SYSTEM
K062396
Sorin Group Deutschland GmbH
Cardiovascular · 43d
Cleared Jun 02, 2006
STOCKERT S5 SYSTEM
K060053
Sorin Group Deutschland GmbH
Cardiovascular · 147d
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 Sep 04, 1998
STOCKERT COMPACT SYSTEM
K982014
Stoeckert Instrumente
Cardiovascular · 88d

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.