Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart D — Cardiovascular Prosthetic Devices](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices) → [21 CFR 870.3470](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3470) → OMR — Vessel Guard Or Cover

# OMR · Vessel Guard Or Cover

_Cardiovascular · 21 CFR 870.3470 · Class 2_

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

## Overview

- **Product Code:** OMR
- **Device Name:** Vessel Guard Or Cover
- **Regulation:** [21 CFR 870.3470](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3470)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **Implant:** yes

## 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.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K111048](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/OMR/K111048.md) | SYNTHES SCOUT TACK FIXATION | Synthes Spine | Jun 14, 2012 | SESU |
| [K111137](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/OMR/K111137.md) | HYDROFIX VASO SHIELD | Mimedx Group, Inc. | May 20, 2011 | SESU |
| [K101805](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/OMR/K101805.md) | HYDROFIX VASO SHIELD | Mimedx Group, Inc. | Apr 8, 2011 | SESU |
| [K103558](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/OMR/K103558.md) | SYNTHES SCOUT VESSEL GUARD | Synthes Spine | Feb 18, 2011 | SESU |
| [K101826](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/OMR/K101826.md) | HYDROFIX VASO SHIELD, MODEL HVS-001-0610 | Mimedx Group, Inc. | Jul 28, 2010 | SESU |
| [K100984](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/OMR/K100984.md) | XYLOS VESSEL GUARD | Xylos Corporation | Jul 7, 2010 | SESU |
| [K100905](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/OMR/K100905.md) | HYDROFIX SURGICAL SHEET | Mimedx Group, Inc. | Jun 2, 2010 | SESE |
| [K093551](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/OMR/K093551.md) | PARADIS VASO SHIELD | Spinemedica, LLC | Dec 24, 2009 | SESU |
| [K090022](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/OMR/K090022.md) | PARADIS VASO SHIELD | Spinemedica, LLC | Apr 20, 2009 | SESU |
| [K082782](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/OMR/K082782.md) | REPLICATION MEDICAL VESSEL GUARD | Replication Medical, Inc. | Apr 2, 2009 | SESU |

## Top Applicants

- Mimedx Group, Inc. — 4 clearances
- Spinemedica, LLC — 2 clearances
- Synthes Spine — 2 clearances
- Replication Medical, Inc. — 1 clearance
- Xylos Corporation — 1 clearance

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

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