← Product Code [DWZ](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWZ) · K870186

# ENDOMYOCARDIAL BIOPSY DEVICE (K870186)

_Mansfield Scientific, Inc. · DWZ · Feb 20, 1987 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWZ/K870186

## Device Facts

- **Applicant:** Mansfield Scientific, Inc.
- **Product Code:** [DWZ](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWZ.md)
- **Decision Date:** Feb 20, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4075
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

An endomyocardial biopsy device is a device used in a catheterization procedure to remove samples of tissue from the inner wall of the heart.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWZ/K870186](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWZ/K870186)

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