# K103520: Carpentier-Edwards Physio Tricuspid Annuloplasty Ring

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jun 24, 2011 after 206 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 K923367 (1993). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020864: Edwards MC Tricuspid Annuloplasty System, Model 4900, Edwards Lifesciences, LLC (2002) Summary page 1.
- K923367: Cosgrove Edwards Annuloplasty System, Model 4600, Baxter Healthcare Corp (1993) Summary page 1.
- K912554: Annuloplasty Rings, Model 4400 Mirtal and 4500 Tri, Baxter Healthcare Corp (1991) Summary page 1.

## Most influential descendants
- K163608: HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm (2017), 1 descendant of its own
- K260498: TriMemo™ SEMIRIGID ANNULOPLASTY RING (2026), 0 descendants of its own
- K171431: HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm (2017), 0 descendants of its own

## Indications for use
The Carpentier-Edwards Physio Tricuspid annuloplasty ring, model 6200, is intended for use in patients with tricuspid valvular insufficiency. It is intended to correct annular dilatation, increase leaflet coaptation, reinforce annular suture lines, and prevent further dilatation of the annulus.

Source page: https://510kreport.com/device/K103520
Methodology: https://510kreport.com/methodology