Boomerang

Basic Information

• Brand Name: Boomerang
• Primary DI: 00860013182304
• Version / Model: BMGVT080
• Company Name: Aveera Medical Inc.
• Labeler DUNS: 119410497
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-14
• Public Version: 1
• Public Version Date: 2025-07-22
• Public Version Status: New
• Public Device Record Key: 115ddd0f-1a91-4b8f-b757-ca6b88a360de

Device Description

The Boomerang 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 retracted, the basket cutting elements disrupt the venous valves, facilitating retrograde vein flow.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MGZ	Valvulotome	Cardiovascular	870.4885	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62527	Valvulotome, percutaneous	A sterile, flexible tube with an exposable blade assembly at its distal end designed to incise/excise peripheral venous valves to allow retrograde flow of blood. It is introduced percutaneously over an in-situ guidewire into a vein before being advanced distally to the valves, where the cutting implement is exposed using controls at the proximal end. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860013182304	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K250105	000

Device Sizes

Type	Value	Unit	Text
Guidewire Diameter	0.018	Inch
Catheter Gauge	4	French
Catheter Working Length	80	Centimeter