# K980487: Carpenter-Edwards Classic Ring with Duraflo Treatment Models 4425 (Mitral) and 4525 (Tricuspid), Carpenter-Edwards Physm

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Edwards
- Decided: Jul 7, 1998 after 148 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Carpentier-Edwards® Classic™ Annuloplasty Ring, Models 4400 and 4500: named in the summary without a submission number
- (no number) Carpentier-Edwards Physio® Annuloplasty Ring, Model 4450: named in the summary without a submission number
- (no number) Cosgrove-Edwards® Annuloplasty System, Model 4600: named in the summary without a submission number

## Indications for use
The intended uses of Baxter's Annuloplasty ring products with Duraflo Treatment are intended for use in patients to correct annular dilatation, increase leaflet coaptation, reinforce annular suture lines and prevent further dilatation of the annulus.

Source page: https://510kreport.com/device/K980487
Methodology: https://510kreport.com/methodology