# K070488: Micardia Annuloplasty Band DR

- Pathway: 510(k) (Traditional)
- Applicant: Micardia Corporation
- Decided: Sep 4, 2008 after 562 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: 2 generations back to K011395 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011395: Medtronic Colvin-Galloway Future Annuloplasty Band, Model 638B, Medtronic Vascular (2001)
- K052860: CG Future Annuloplasty Band, Medtronic Heart Valves (2005)

## Indications for use
The Annuloplasty Band DR and Annuloplasty Ring DR are indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling.

Source page: https://510kreport.com/device/K070488
Methodology: https://510kreport.com/methodology