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ATS Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SR

FDA 510(k)

Class II (US FDA 510(k))

510(k) K072655

by Genesee Biomedical, Inc.

Identifiers

510(k) Number
K072655 FDA 510(k)
FDA Product Code
KRH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.3800 FDA 510(k)
Regulation Number
870.3800 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ATS Simulus Semi-Rigid Mitral Annuloplasty Ring is an implantable device used during mitral valve repair surgery. It consists of a braided polyester body with an MP35N wire stiffener and spring mechanism to provide structural support to the atrioventricular annulus.

This device is supplied as a single-use implant and is regulated under FDA 510(k) clearance with product code KRH. It is classified as a Ring, Annuloplasty in the cardiovascular medical specialty and was determined to be substantially equivalent on October 23, 2007.

Frequently asked questions

What is the ATS Simulus Semi-Rigid Mitral Annuloplasty Ring Model 800SR used for?

The ATS Simulus Semi-Rigid Mitral Annuloplasty Ring Model 800SR is an implantable device used during mitral valve repair surgery to provide structural support to the atrioventricular annulus, helping restore proper valve function by stabilizing the mitral ring.

How is the ATS Simulus Semi-Rigid Mitral Annuloplasty Ring Model 800SR supplied and is it reusable?

The device is supplied as a single-use implant, meaning it is intended for one surgical procedure only and must not be reprocessed or reused due to risks of material degradation, contamination, or compromised structural integrity after implantation.

What materials make up the ATS Simulus Semi-Rigid Mitral Annuloplasty Ring Model 800SR?

The ring consists of a braided polyester body combined with an MP35N wire stiffener and spring mechanism, which together provide the necessary semi-rigid structural support to the mitral annulus during and after valve repair.

What regulatory pathway was used for the ATS Simulus Semi-Rigid Mitral Annuloplasty Ring Model 800SR?

The device received FDA 510(k) clearance under product code KRH, determined to be substantially equivalent to a predicate device on October 23, 2007, and is classified as a Class II medical device in the cardiovascular specialty.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Ats Simulus Semi-rigid Mitral Annuloplasty Ring, Model 800sr, ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING… - FDA.report, 510(k) Premarket Notification, PDF 510(k) InfrinationSEPTFMBER Sumary'

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Genesee Biomedical, Inc.

Sources (1)

  • FDA 510(k) K072655 24 fields · synced Sep 27, 2026