# K965137: Fogarty Valvulotome Model 700091

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Edwards
- Decided: Jun 4, 1997 after 163 days
- Product code: MGZ (Valvulotome)
- Device class: 2
- Regulation: 21 CFR 870.4885
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K925283 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925283: Valvulotome, Intramed Laboratories, Inc. (1994) Summary page 1.

## Indications for use
The Fogarty® Valvulotome is indicated for use in veins during in situ or autologous bypass graft procedures.

Source page: https://510kreport.com/device/K965137
Methodology: https://510kreport.com/methodology