Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4220](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4220) → DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass # DTQ · Console, Heart-Lung Machine, Cardiopulmonary Bypass _Cardiovascular · 21 CFR 870.4220 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ ## Overview - **Product Code:** DTQ - **Device Name:** Console, Heart-Lung Machine, Cardiopulmonary Bypass - **Regulation:** [21 CFR 870.4220](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4220) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **Life-sustaining:** yes ## Identification A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 52) Showing 20 most recent of 52 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K232291](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K232291.md) | Essenz HLM, Essenz ILBM | Livanova Deutschland, GmbH | Aug 24, 2023 | SESE | | [K221895](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K221895.md) | Terumo Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | Apr 18, 2023 | SESE | | [K221373](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K221373.md) | Essenz HLM | Livanova Deutschland, GmbH | Mar 9, 2023 | SESE | | [K210130](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K210130.md) | Stockert S5 System | Livanova Deutschland, GmbH | Apr 5, 2021 | SESE | | [K202125](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K202125.md) | Century Perfusion System | Century Hlm, LLC | Mar 7, 2021 | SESE | | [K190282](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K190282.md) | Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) | Spectrum Medical , Ltd. | May 24, 2019 | SESE | | [K173834](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K173834.md) | Quantum Pump Console | Spectrum Medical , Ltd. | May 25, 2018 | SESE | | [K172220](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K172220.md) | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | Aug 17, 2017 | SESE | | [K163531](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K163531.md) | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | Jun 7, 2017 | SESE | | [K153376](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K153376.md) | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | Dec 16, 2015 | SESE | | [K151349](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K151349.md) | Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | Aug 27, 2015 | SESE | | [K133598](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K133598.md) | CARDIOHELP SYSTEM | Maquet Cardiopulmonary, AG | May 21, 2014 | SESE | | [K131041](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K131041.md) | ADVANCED PERFUSION SYSTEM 1 | Terumo Cardiovascular Systems Corp. | Feb 20, 2014 | SESE | | [K102726](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K102726.md) | CARDIOHELP SYSTEM | Maquet Cardiopulmonary, AG | Apr 4, 2011 | SESE | | [K103762](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K103762.md) | SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE | Sorin Group Deutschland GmbH | Jan 20, 2011 | SESE | | [K093882](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K093882.md) | SORIN C5 SYSTEM MODEL 58-00-00 | Sorin Group Deutschland GmbH | Jan 15, 2010 | SESE | | [K092463](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K092463.md) | SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM | Sorin Group Deutschland GmbH | Nov 5, 2009 | SESE | | [K090006](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K090006.md) | LIFEBRIDGE B2T, MODEL 7001 | Lifebridge Medizintechnik AG | Oct 15, 2009 | SESE | | [K091007](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K091007.md) | AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05 | Sorin Group Deutschland GmbH | Jul 2, 2009 | SESE | | [K080832](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K080832.md) | STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER | Sorin Group Deutschland GmbH | Jul 30, 2008 | SESE | ## Top Applicants - Sorin Group Deutschland GmbH — 8 clearances - Terumo Cardiovascular Systems Corporation — 5 clearances - 3M Health Care, Sarns — 5 clearances - Stoeckert Instrumente — 3 clearances - Shiley, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com