# K132190: Expandable Lemaitre Valvulotome, Over-the-Wire Lemaitre Valvulotome

- Pathway: 510(k) (Traditional)
- Applicant: LeMaitre Vascular, Inc.
- Decided: Aug 5, 2013 after 21 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: 2 generations back to K946352 (1995). 2 ancestors in all.
4 later devices descend from it; 3 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)
- K080178: Valvulotome by Koven, Koven Technology, Inc. (2008) Summary page 2.

## Most influential descendants
- K221902: LimFlow Vector (2022), 1 descendant of its own
- K260188: LimFlow Vector (2026), 0 descendants of its own
- K250105: Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) (2025), 0 descendants of its own
- K140042: 1.5MM Hydro Expandable Lemaitre Valvulotome (2014), 0 descendants of its own

## Indications for use
It is used for the treatment of vascular disorders and more particularly for excising or disrupting venous valves.

Source page: https://510kreport.com/device/K132190
Methodology: https://510kreport.com/methodology