← Product Code [DTX](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTX) · K863902

# MODIFIED SARNS MEMBRANE OXYGENATOR (K863902)

_3M Health Care, Sarns · DTX · Dec 11, 1986 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTX/K863902

## Device Facts

- **Applicant:** 3M Health Care, Sarns
- **Product Code:** [DTX](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTX.md)
- **Decision Date:** Dec 11, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4300
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A cardiopulmonary bypass gas control unit is a device used to control and measure the flow of gas into the oxygenator. The device is calibrated for a specific gas.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTX/K863902](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTX/K863902)

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