← Product Code [DWA](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA) · K936091

# MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER (K936091)

_Medtronic Bio-Medicus, Inc. · DWA · Dec 23, 1994 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA/K936091

## Device Facts

- **Applicant:** Medtronic Bio-Medicus, Inc.
- **Product Code:** [DWA](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA.md)
- **Decision Date:** Dec 23, 1994
- **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.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA/K936091](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWA/K936091)

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