← Product Code [OMR](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/OMR) · K101826

# HYDROFIX VASO SHIELD, MODEL HVS-001-0610 (K101826)

_Mimedx Group, Inc. · OMR · Jul 28, 2010 · Cardiovascular · SESU_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/OMR/K101826

## Device Facts

- **Applicant:** Mimedx Group, Inc.
- **Product Code:** [OMR](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/OMR.md)
- **Decision Date:** Jul 28, 2010
- **Decision:** SESU
- **Submission Type:** Special
- **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/OMR/K101826](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/OMR/K101826)

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