# K250105: Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)

- Pathway: 510(k) (Traditional)
- Applicant: Aveera Medical, Inc.
- Decided: Jul 3, 2025 after 169 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: 3 generations back to K946352 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132190: Expandable Lemaitre Valvulotome, Over-the-Wire Lemaitre Valvulotome, LeMaitre Vascular, Inc. (2013) Summary page 5.

## Indications for use
The Boomerang™ Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves.

Source page: https://510kreport.com/device/K250105
Methodology: https://510kreport.com/methodology