← Product Code [DXZ](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ) · K011487

# CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS (K011487)

_Somanetics Corp. · DXZ · Nov 21, 2001 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ/K011487

## Device Facts

- **Applicant:** Somanetics Corp.
- **Product Code:** [DXZ](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ.md)
- **Decision Date:** Nov 21, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.3470
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ/K011487](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ/K011487)

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