← Back to catalogue

Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250105

by Aveera Medical, Inc.

Identifiers

510(k) Number
K250105 FDA 510(k)
FDA Product Code
MGZ FDA 510(k)
Models / Variants
Boomerang Valvulotome (BMGVT080) FDA 510(k)
Boomerang Push Valvulotome (BMGPVT125) FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.4885 FDA 510(k)
Regulation Number
870.4885 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Boomerang Valvulotome is a valvulotome device intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves. It is designed as an over-the-wire (OTW) catheter to disrupt venous valves in the lower limb.

The device is positioned percutaneously under fluoroscopic guidance such that the distal tip is advanced. It is supplied as a sterile, single-use device. It received FDA 510(k) clearance under K250105 on 2025-07-03 and is classified under product code MGZ with regulation number 870.4885.

Frequently asked questions

What is the Boomerang Valvulotome used for?

The Boomerang Valvulotome is intended for the treatment of vascular disorders, specifically to excise or disrupt venous valves in the lower limb. It is used percutaneously under fluoroscopic guidance to advance the distal tip to the target site for valve disruption.

How is the Boomerang Valvulotome supplied and is it reusable?

The device is supplied as a sterile, single-use catheter. It is not designed for reuse; each unit must be discarded after one procedure to maintain sterility and prevent cross-contamination, as indicated in the device description.

What model numbers are available for the Boomerang Valvulotome?

Two model numbers are available: Boomerang Valvulotome (BMGVT080) and Boomerang Push Valvulotome (BMGPVT125). These designations distinguish the specific configurations within the product line, as listed in the device name field.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125 ..., Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125 ..., AccessGUDID - DEVICE: Boomerang (00860013182311)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Aveera Medical, Inc.

Sources (1)

  • FDA 510(k) K250105 24 fields · synced Oct 6, 2026