# K083623: Carpentier-Mccarthy-Adams Imr Etlogix Annuloplasty Ring, Model 4100

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Apr 15, 2009 after 128 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: 3 generations back to K923367 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912554: Annuloplasty Rings, Model 4400 Mirtal and 4500 Tri, Baxter Healthcare Corp (1991) Summary page 1.
- K926138: Carpentier-Edwards Physio Annuloplasty Ring, Baxter Healthcare Corp (1993) Summary page 1.
- K032250: Geoform Annuloplasty Ring, Mitral Model 4200, Edwards Lifesciences, LLC (2003) Summary page 1.

## Indications for use
The Carpentier-McCarthy-Adams'IMR ETIogix Mitral Annuloplasty Ring is indicated for the correction of mitral valve insufficiency where the lesions are not so severe as to require total valve replacement. The decision to undertake valvuloplasty can be made only after visual analysis of the lesion present. The most favorable conditions for valvuloplasty using an annuloplasty ring are a combination of a distended natural valve ring associated with supple valve cusps and normal chordae tendinae. The remodeling valvuloplasty technique with a prosthetic ring may be used in all acquired or congenital mitral insufficiencies With dilatation and deformation of the fibrous mitral annulus. For Type I mitral insufficiencies with no subvalvular lesions and normal valvular movements, this ring technique used alone is sufficient. However, the ring technique must be associated with mitral valvuloplasty repair in Type II insufficiencies with a prolapsed valve due to elongation or rupture of the chordae tendineae and in Type III insufficiencies with limitation of valvular movements due to fusion of the commissures or chordae tendineae, or chordal hypertrophy.

Source page: https://510kreport.com/device/K083623
Methodology: https://510kreport.com/methodology