← Product Code [KRH](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH) · K083683

# ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC (K083683)

_Genesee Biomedical, Inc. · KRH · Feb 25, 2009 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH/K083683

## Device Facts

- **Applicant:** Genesee Biomedical, Inc.
- **Product Code:** [KRH](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH.md)
- **Decision Date:** Feb 25, 2009
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 870.3800
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.

## Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH/K083683](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH/K083683)

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