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Boomerang

FDA UDI

Class II (US FDA UDI)

by Aveera Medical, Inc.

Identity

Trade Name
Boomerang FDA UDI
Generic Name
Valvulotome, percutaneous FDA UDI
Device Name
The Boomerang Push Valvulotome is an over-the-wire (OTW) catheter designed to disrupt venous valves in the lower limb. The catheter is positioned percutaneously under fluoroscopic guidance such that the distal tip is advanced across the target venous valve. The catheter has a self-centering basket with shielded cutting blades. As the catheter is advanced, the basket cutting elements disrupt the venous valves, facilitating retrograde vein flow. FDA UDI
Model / Reference
BMGPVT125 FDA UDI
Description
The Boomerang Push Valvulotome is an over-the-wire (OTW) catheter designed to disrupt venous valves in the lower limb. The catheter is positioned percutaneously under fluoroscopic guidance such that the distal tip is advanced across the target venous valve. The catheter has a self-centering basket with shielded cutting blades. As the catheter is advanced, the basket cutting elements disrupt the venous valves, facilitating retrograde vein flow. FDA UDI

Identifiers

Primary DI / UDI-DI
00860013182311 FDA UDI
510(k) Number
K250105 FDA UDI
FDA Product Code
MGZ FDA UDI
GMDN Term
Valvulotome, percutaneous FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4885 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Catheter Working Length — 125 Centimeter FDA UDI
Catheter Gauge — 4 French FDA UDI
Guidewire Diameter — 0.018 Inch FDA UDI

Category: Valvulotome, percutaneous

Boomerang by Aveera Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Valvulotome, percutaneous.

Cleared under the same submission

K250105 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aveera Medical, Inc.

Sources (1)

  • FDA UDI 95ddef0d-18a9-4e90-99c9-288d6f251ca0 36 fields · synced Jun 1, 2026