Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4380](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4380) → DWA — Control, Pump Speed, Cardiopulmonary Bypass # DWA · Control, Pump Speed, Cardiopulmonary Bypass _Cardiovascular · 21 CFR 870.4380 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA ## Overview - **Product Code:** DWA - **Device Name:** Control, Pump Speed, Cardiopulmonary Bypass - **Regulation:** [21 CFR 870.4380](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4380) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **Life-sustaining:** yes ## Identification A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 37) Showing 20 most recent of 37 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K232788](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA/K232788.md) | INSPIRA ART100 | Inspira Technologies Oxy B.H.N. , Ltd. | May 24, 2024 | SESE | | [K230698](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA/K230698.md) | Anivia SG1000 Pump Console | Apmtd, Inc. | Apr 18, 2023 | SESE | | [K221491](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA/K221491.md) | Anivia SG1000 Pump Console | Apmtd, Inc. | Feb 3, 2023 | SESE | | [K192838](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA/K192838.md) | Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure | Spectrum Medical , Ltd. | Apr 13, 2020 | SESE | | [K200306](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA/K200306.md) | CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit | Abbott (Formerly Thoratec Corporation) | Mar 6, 2020 | SESE | | [K191557](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA/K191557.md) | CentriMag Acute Circulatory Support System | Thoratec Corporation (Now Part of Abbott) | Jul 10, 2019 | SESE | | [K131964](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA/K131964.md) | BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE | Medtronic, Inc. | Jul 24, 2013 | SESE | | [K131179](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA/K131179.md) | CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR | Thoratec Corp | Jul 18, 2013 | SESE | | [K112225](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA/K112225.md) | SORIN CENTRIFUGAL PUMP 5 (CP5) | Sorin Group Deutschland GmbH | Sep 20, 2011 | SESE | | [K103468](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA/K103468.md) | STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS) | Sorin Group Deutschland GmbH | Jan 20, 2011 | SESE | | [K102129](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA/K102129.md) | LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR | Levitronix, LLC | Aug 27, 2010 | SESE | | [K093832](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA/K093832.md) | LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES | Levitronix, LLC | Jan 13, 2010 | SESE | | [K091008](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA/K091008.md) | STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55 | Sorin Group Deutschland GmbH | Jul 15, 2009 | SESE | | [K090004](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA/K090004.md) | LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES | Levitronix, LLC | Jan 15, 2009 | SESE | | [K083340](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA/K083340.md) | LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE | Levitronix, LLC | Nov 26, 2008 | SESE | | [K081221](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA/K081221.md) | LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE | Levitronix, LLC | Jun 19, 2008 | SESE | | [K080824](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA/K080824.md) | BIO-CONSOLE 560 | Medtronic Perfusion Systems | May 7, 2008 | SESE | | [K070286](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA/K070286.md) | BIO-CONSOLE, MODEL 560 | Medtronic | May 22, 2007 | SESE | | [K061369](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA/K061369.md) | TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500 | Cardiacassist, Inc. | Aug 22, 2006 | SESE | | [K053630](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA/K053630.md) | LEVITRONIX CENTRIMAG PRIMARY CONSOLE | Levitronix, LLC | Jan 26, 2006 | SESE | ## Top Applicants - Medtronic Bio-Medicus, Inc. — 6 clearances - Levitronix, LLC — 6 clearances - Stockert Instrumente GmbH — 3 clearances - Sorin Group Deutschland GmbH — 3 clearances - Bio Medicus, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA) **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. 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