# K103812: Mitra-Lift

- Pathway: 510(k) (Traditional)
- Applicant: Sciencity Co., Ltd.
- Decided: May 18, 2011 after 140 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: 4 generations back to K893678 (1989). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052970: Simplici-T Annuloplasty System, Medtronic Heart Valves (2006) Summary page 2.

## Indications for use
The Mitra-Lift Set is indicated as reinforcement for repair of the human mitral valves damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.

Source page: https://510kreport.com/device/K103812
Methodology: https://510kreport.com/methodology