← Product Code [DWA](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA) · K924206 # MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E (K924206) _Medtronic Bio-Medicus, Inc. · DWA · May 7, 1993 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA/K924206 ## Device Facts - **Applicant:** Medtronic Bio-Medicus, Inc. - **Product Code:** [DWA](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA.md) - **Decision Date:** May 7, 1993 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.4380 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Regulatory 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. --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA/K924206](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA/K924206) **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 as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA/K924206