Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800SC
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K083683 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, Model 800sc, is a ring used for mitral annuloplasty. It is a semi-rigid device designed for valve repair. The device is classified as a Ring, Annuloplasty, and is used in cardiovascular procedures.
The Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800sc, is supplied by Genesee Biomedical, Inc. and has been granted FDA 510K authorization. The device is part of a portfolio of cardiac surgery devices and is used in mitral valve repair. The device has a specific product code, KRH, and regulation number, 870.3800.
Frequently asked questions
What is the ATS Simulus Semi-Rigid Mitral Annuloplasty Ring used for?
The ATS Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800sc, is used for mitral annuloplasty, a procedure to repair the mitral valve in the heart.
Is the ATS Simulus Semi-Rigid Mitral Annuloplasty Ring supplied sterile?
The description does not specify if the device is supplied sterile, but it is designed for use in cardiovascular procedures, where sterility is typically required.
What is the regulatory status of the ATS Simulus Semi-Rigid Mitral Annuloplasty Ring?
The ATS Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800sc, has been granted FDA 510K authorization, indicating it is substantially equivalent to a predicate device.
What is the product code for the ATS Simulus Semi-Rigid Mitral Annuloplasty Ring?
The product code for the ATS Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800sc, is KRH, and the regulation number is 870.3800.
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 800sc, SimuPlus™ Flexible Annuloplasty Ring & Band | Medtronic, 510(k) Premarket Notification, Products - Genesee BioMedical Inc. | Design Beyond Standard, Simulus™ 800SC34 BAND SIM SC 800SC34 SEMI-RIGID GUDID Device - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K083683 | Class II | Active |
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Manufacturer
- Manufacturer
- Genesee Biomedical, Inc.
Sources (1)
- FDA 510(k) K083683 24 fields · synced Sep 24, 2026