# K980723: 2.0MM Expandable Lemaitre Valvulotome (Elv 2.0- GNT)

- Pathway: 510(k) (Traditional)
- Applicant: Vascutech, Inc.
- Decided: Feb 12, 1999 after 353 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K111884: Over-the-Wire Expandable Lemaitre Valvulotome (2011), 0 descendants of its own

## Indications for use
Cuts saphenous vein valves during in situ bypass procedures in lower extremities.

Source page: https://510kreport.com/device/K980723
Methodology: https://510kreport.com/methodology