# K946352: Lemaitre Valvulotome II

- Pathway: 510(k) (Traditional)
- Applicant: Vascutech, Inc.
- Decided: Jun 21, 1995 after 173 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.
6 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K080178: Valvulotome by Koven (2008), 5 descendants of its own
- K132190: Expandable Lemaitre Valvulotome, Over-the-Wire Lemaitre Valvulotome (2013), 4 descendants of its own
- 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

Source page: https://510kreport.com/device/K946352
Methodology: https://510kreport.com/methodology