# K984435: Medtronic Khonsari Annuloplasty Band, Model H609M

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular
- Decided: Jan 7, 1999 after 27 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
Longest line of descent: 1 generation back to K905175 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905175: Pti Annuloplasty Ring (Sterile), Pioneering Technologies, Inc. (1992) Summary page 1.
- K960356: Posterior Annuloplasty Band (Model 607), The Heart Valve Div. Medtronic Cardiovascular Surg (1996) Summary page 1.
- K923367: Cosgrove Edwards Annuloplasty System, Model 4600, Baxter Healthcare Corp (1993) Summary page 1.

## Indications for use
For use in those patients undergoing surgery of diseased or damaged mitral valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty bands provide support for and restrict dilatation of the posterior mitral valve annulus.

Source page: https://510kreport.com/device/K984435
Methodology: https://510kreport.com/methodology