Product Code: DTQ FDA class 2 21 CFR 870.4220

Console, Heart-Lung Machine, Cardiopulmonary Bypass

Cardiovascular

The Heart-Lung Machine Console for Cardiopulmonary Bypass is a life-sustaining cardiovascular device that integrates and controls the pumps, alarms, and monitoring functions of an extracorporeal circulation system, maintaining blood flow and gas exchange for the patient during open-heart surgery. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DTQ and it is regulated under 21 CFR 870.4220 within the Cardiovascular medical specialty. This device is designated as life-sustaining or life-supporting.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: DTQ
Device Class: FDA class 2
Regulation Number: 870.4220
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 52 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K232291	Essenz HLM, Essenz ILBM	Aug 24, 2023	Substantially Equivalent	Livanova Deutschland, GmbH
K221895	Terumo Advanced Perfusion System 1	Apr 18, 2023	Substantially Equivalent	Terumo Cardiovascular Systems Corporation
K221373	Essenz HLM	Mar 09, 2023	Substantially Equivalent	Livanova Deutschland, GmbH
K210130	Stockert S5 System	Apr 05, 2021	Substantially Equivalent	Livanova Deutschland, GmbH
K202125	Century Perfusion System	Mar 07, 2021	Substantially Equivalent	Century Hlm, LLC
K190282	Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)	May 24, 2019	Substantially Equivalent	Spectrum Medical , Ltd.
K173834	Quantum Pump Console	May 25, 2018	Substantially Equivalent	Spectrum Medical , Ltd.
K172220	Advanced Perfusion System 1	Aug 17, 2017	Substantially Equivalent	Terumo Cardiovascular Systems Corporation
K163531	Advanced Perfusion System 1	Jun 07, 2017	Substantially Equivalent	Terumo Cardiovascular Systems Corporation
K153376	Advanced Perfusion System 1	Dec 16, 2015	Substantially Equivalent	Terumo Cardiovascular Systems Corporation
K151349	Advanced Perfusion System 1	Aug 27, 2015	Substantially Equivalent	Terumo Cardiovascular Systems Corporation
K133598	CARDIOHELP SYSTEM	May 21, 2014	Substantially Equivalent	Maquet Cardiopulmonary, AG
K131041	ADVANCED PERFUSION SYSTEM 1	Feb 20, 2014	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K102726	CARDIOHELP SYSTEM	Apr 04, 2011	Substantially Equivalent	Maquet Cardiopulmonary, AG
K103762	SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE	Jan 20, 2011	Substantially Equivalent	Sorin Group Deutschland GmbH
K093882	SORIN C5 SYSTEM MODEL 58-00-00	Jan 15, 2010	Substantially Equivalent	Sorin Group Deutschland GmbH
K092463	SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM	Nov 05, 2009	Substantially Equivalent	Sorin Group Deutschland GmbH
K090006	LIFEBRIDGE B2T, MODEL 7001	Oct 15, 2009	Substantially Equivalent	Lifebridge Medizintechnik AG
K091007	AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05	Jul 02, 2009	Substantially Equivalent	Sorin Group Deutschland GmbH
K080832	STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER	Jul 30, 2008	Substantially Equivalent	Sorin Group Deutschland GmbH
K071318	MODIFICATION TO: STOCKERT S5 SYSTEM	Jul 06, 2007	Substantially Equivalent	Sorin Group Deutschland GmbH
K070213	PERFORMER CBP SYSTEM	Mar 21, 2007	Substantially Equivalent	Rand S.R.L.
K062396	MODIFICATION TO STOCKERT S5 SYSTEM	Sep 28, 2006	Substantially Equivalent	Sorin Group Deutschland GmbH
K060053	STOCKERT S5 SYSTEM	Jun 02, 2006	Substantially Equivalent	Sorin Group Deutschland GmbH
K052555	MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB	Mar 15, 2006	Substantially Equivalent	Rand S.R.L.
K022947	ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH	Mar 20, 2003	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K030141	MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100	Feb 26, 2003	Substantially Equivalent	Cardiovention, Inc.
K021694	CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100	Jan 08, 2003	Substantially Equivalent	Cardiovention, Inc.
K020571	STOCKERT CENTRIFUGAL PUMP CONSOLE	Sep 23, 2002	Substantially Equivalent	Stockert Instrumente GmbH
K011088	SIII ALARM AMPLIFIER	May 02, 2001	Substantially Equivalent	Stockert Instrumente GmbH
K002118	STOCKERT COMPACT SYSTEM VERSION 2.0	Aug 09, 2000	Substantially Equivalent	Stoeckert Instrumente
K002116	S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0	Aug 09, 2000	Substantially Equivalent	Medical Device Consultants, Inc.
K982014	STOCKERT COMPACT SYSTEM	Sep 04, 1998	Substantially Equivalent	Stoeckert Instrumente
K964017	AFFINITY BLOOD PUMP SYSTEM	Aug 05, 1997	Substantially Equivalent	Avecor Cardiovascular, Inc.
K943803	JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM	Jan 30, 1996	Substantially Equivalent	Janus Biomedical, Inc.
K950990	STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE	Jan 19, 1996	Substantially Equivalent	Stoeckert Instrumente
K942582	SORIN BLOOD CARDIOPLEGIA CONSOLE	Jan 27, 1995	Substantially Equivalent	Sorin Biomedical, Inc.
K915183	SARNS 8000 MODULAR PERFUSION SYSTEM	Jul 08, 1992	Substantially Equivalent	3M Health Care, Sarns
K871131	SARNS 9000 HEART-LUNG CONSOLE	May 21, 1987	Substantially Equivalent	3M Health Care, Sarns
K870976	ONGUARD 1000, CATALOG #043611-000 & 043611-001	May 06, 1987	Substantially Equivalent	Cobe Laboratories, Inc.
K863960	STOCKERT-SHILEY CAPS BATTERY MODULE	Dec 11, 1986	Substantially Equivalent	Shiley, Inc.
K863541	STOCKERT-SHILEY CAPS HLM INTERFACE	Nov 18, 1986	Substantially Equivalent	Shiley, Inc.
K862973	STOCKERT-SHILEY CAPS TIMER MODULE	Oct 01, 1986	Substantially Equivalent	Shiley, Inc.
K861388	SARNS PORTABLE POWER MODULE	Jun 23, 1986	Substantially Equivalent	3M Health Care, Sarns
K851615	CENTRIMED SYSTEM 1 W/MANUAL PUMP DRIVE	Jun 19, 1985	Substantially Equivalent	Centrimed Corp.
K851614	CENTRIMED SYSTEM 1 W/24 VOLT BATTERY POWER SUPPLY	Jun 19, 1985	Substantially Equivalent	Centrimed Corp.
K842138	COBE EMERGENCY POWER SOURCE 43610-000	Aug 03, 1984	Substantially Equivalent	Cobe Laboratories, Inc.
K822068	GAMBRO PUMP CONSOLE CSL	Aug 24, 1982	Substantially Equivalent	Gambro, Inc.
K813034	POLYSTAN HEART LUNG MACHINE SYS	Nov 27, 1981	Substantially Equivalent	Advocacy International, Ltd.
K801097	SARNS 7000 MONITOR MODULE	May 20, 1980	Substantially Equivalent	3M Health Care, Sarns
K772001	SARNES HELP	Nov 02, 1977	Substantially Equivalent	3M Health Care, Sarns
K770002	CONSOLE, MOBILE FOR 3 PUMPS W/MASTS	Mar 07, 1977	Substantially Equivalent	Cobe Laboratories, Inc.