Boomerang

GUDID 00860013182311

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.

Aveera Medical Inc.

Valvulotome, percutaneous

• Primary Device ID: 00860013182311
• NIH Device Record Key: 95ddef0d-18a9-4e90-99c9-288d6f251ca0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Boomerang
• Version Model Number: BMGPVT125
• Company DUNS: 119410497
• Company Name: Aveera Medical Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 4405671793
• Email: cchapek@aveeramedical.com
• Phone: 4405671793
• Email: cchapek@aveeramedical.com
• Phone: 4405671793
• Email: cchapek@aveeramedical.com
• Phone: 4405671793
• Email: cchapek@aveeramedical.com
• Phone: 4405671793
• Email: cchapek@aveeramedical.com
• Phone: 4405671793
• Email: cchapek@aveeramedical.com
• Phone: 4405671793
• Email: cchapek@aveeramedical.com
• Phone: 4405671793
• Email: cchapek@aveeramedical.com
• Phone: 4405671793
• Email: cchapek@aveeramedical.com
• Phone: 4405671793
• Email: cchapek@aveeramedical.com
• Phone: 4405671793
• Email: cchapek@aveeramedical.com
• Phone: 4405671793
• Email: cchapek@aveeramedical.com
• Phone: 4405671793
• Email: cchapek@aveeramedical.com

Device Dimensions

• Catheter Working Length: 125 Centimeter
• Catheter Gauge: 4 French
• Guidewire Diameter: 0.018 Inch
• Catheter Working Length: 125 Centimeter
• Catheter Gauge: 4 French
• Guidewire Diameter: 0.018 Inch
• Catheter Working Length: 125 Centimeter
• Catheter Gauge: 4 French
• Guidewire Diameter: 0.018 Inch
• Catheter Working Length: 125 Centimeter
• Catheter Gauge: 4 French
• Guidewire Diameter: 0.018 Inch
• Catheter Working Length: 125 Centimeter
• Catheter Gauge: 4 French
• Guidewire Diameter: 0.018 Inch
• Catheter Working Length: 125 Centimeter
• Catheter Gauge: 4 French
• Guidewire Diameter: 0.018 Inch
• Catheter Working Length: 125 Centimeter
• Catheter Gauge: 4 French
• Guidewire Diameter: 0.018 Inch
• Catheter Working Length: 125 Centimeter
• Catheter Gauge: 4 French
• Guidewire Diameter: 0.018 Inch
• Catheter Working Length: 125 Centimeter
• Catheter Gauge: 4 French
• Guidewire Diameter: 0.018 Inch
• Catheter Working Length: 125 Centimeter
• Catheter Gauge: 4 French
• Guidewire Diameter: 0.018 Inch
• Catheter Working Length: 125 Centimeter
• Catheter Gauge: 4 French
• Guidewire Diameter: 0.018 Inch
• Catheter Working Length: 125 Centimeter
• Catheter Gauge: 4 French
• Guidewire Diameter: 0.018 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860013182311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250105

FDA Product Code

• MGZ: Valvulotome

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-22
• Device Publish Date: 2025-07-14

On-Brand Devices [Boomerang]

• 00860013182311: The Boomerang Push Valvulotome is an over-the-wire (OTW) catheter designed to disrupt venous val
• 00860013182304: The Boomerang Valvulotome is an over-the-wire (OTW) catheter designed to disrupt venous valves i