← Product Code [DTQ](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ) · K772001

# SARNES HELP (K772001)

_3M Health Care, Sarns · DTQ · Nov 2, 1977 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K772001

## Device Facts

- **Applicant:** 3M Health Care, Sarns
- **Product Code:** [DTQ](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ.md)
- **Decision Date:** Nov 2, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4220
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K772001](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTQ/K772001)

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