← Product Code [DXS](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXS) · K873802

# PRESSURE BARRIER KIT CAT. NO. PBK-3 (K873802)

_American Omni Medical, Inc. · DXS · Nov 6, 1987 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXS/K873802

## Device Facts

- **Applicant:** American Omni Medical, Inc.
- **Product Code:** [DXS](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXS.md)
- **Decision Date:** Nov 6, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4310
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A cardiopulmonary bypass coronary pressure gauge is a device used in cardiopulmonary bypass surgery to measure the pressure of the blood perfusing the coronary arteries.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXS/K873802](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXS/K873802)

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