# K090428: Ats Simulus Adjustable Flexible Annuloplasty, Model 735 AC

- Pathway: 510(k) (Special)
- Applicant: Genesee Biomedical, Inc.
- Decided: May 7, 2009 after 77 days
- Product code: KRH (Ring, Annuloplasty)
- Device class: 2
- Regulation: 21 CFR 870.3800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Genesee Biomedical Inc.'s SIMULUS® Adjustable Flexible Annuloplasty Ring Model 735AF: named in the summary without a submission number

## Indications for use
The ATS SIMULUS® Adjustable Flexible Annuloplasty Bands Model 735AC are for use in those patients undergoing surgery of diseased or damaged mitral or tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty bands provide support for the mitral or tricuspid annulus and restrict expansion of the annulus

Source page: https://510kreport.com/device/K090428
Methodology: https://510kreport.com/methodology