Boomerang

GUDID 00860013182304

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.

Aveera Medical Inc.

Valvulotome, percutaneous
Primary Device ID00860013182304
NIH Device Record Key115ddd0f-1a91-4b8f-b757-ca6b88a360de
Commercial Distribution StatusIn Commercial Distribution
Brand NameBoomerang
Version Model NumberBMGVT080
Company DUNS119410497
Company NameAveera Medical Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone4405671793
Emailcchapek@aveeramedical.com
Phone4405671793
Emailcchapek@aveeramedical.com
Phone4405671793
Emailcchapek@aveeramedical.com
Phone4405671793
Emailcchapek@aveeramedical.com
Phone4405671793
Emailcchapek@aveeramedical.com
Phone4405671793
Emailcchapek@aveeramedical.com
Phone4405671793
Emailcchapek@aveeramedical.com
Phone4405671793
Emailcchapek@aveeramedical.com
Phone4405671793
Emailcchapek@aveeramedical.com
Phone4405671793
Emailcchapek@aveeramedical.com
Phone4405671793
Emailcchapek@aveeramedical.com
Phone4405671793
Emailcchapek@aveeramedical.com
Phone4405671793
Emailcchapek@aveeramedical.com

Device Dimensions

Guidewire Diameter0.018 Inch
Catheter Gauge4 French
Catheter Working Length80 Centimeter
Guidewire Diameter0.018 Inch
Catheter Gauge4 French
Catheter Working Length80 Centimeter
Guidewire Diameter0.018 Inch
Catheter Gauge4 French
Catheter Working Length80 Centimeter
Guidewire Diameter0.018 Inch
Catheter Gauge4 French
Catheter Working Length80 Centimeter
Guidewire Diameter0.018 Inch
Catheter Gauge4 French
Catheter Working Length80 Centimeter
Guidewire Diameter0.018 Inch
Catheter Gauge4 French
Catheter Working Length80 Centimeter
Guidewire Diameter0.018 Inch
Catheter Gauge4 French
Catheter Working Length80 Centimeter
Guidewire Diameter0.018 Inch
Catheter Gauge4 French
Catheter Working Length80 Centimeter
Guidewire Diameter0.018 Inch
Catheter Gauge4 French
Catheter Working Length80 Centimeter
Guidewire Diameter0.018 Inch
Catheter Gauge4 French
Catheter Working Length80 Centimeter
Guidewire Diameter0.018 Inch
Catheter Gauge4 French
Catheter Working Length80 Centimeter
Guidewire Diameter0.018 Inch
Catheter Gauge4 French
Catheter Working Length80 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100860013182304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MGZValvulotome

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-22
Device Publish Date2025-07-14

On-Brand Devices [Boomerang]

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

Trademark Results [Boomerang]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BOOMERANG
BOOMERANG
98640692 not registered Live/Pending
Dees Creations, Inc.
2024-07-10
BOOMERANG
BOOMERANG
98611107 not registered Live/Pending
Boomerang Storage, LLC
2024-06-20
BOOMERANG
BOOMERANG
98455440 not registered Live/Pending
Boomerang Corp.
2024-03-18
BOOMERANG
BOOMERANG
98455439 not registered Live/Pending
Boomerang Corp.
2024-03-18
BOOMERANG
BOOMERANG
98303578 not registered Live/Pending
Boomerang Water, LLC
2023-12-07
BOOMERANG
BOOMERANG
98303511 not registered Live/Pending
Boomerang Water, LLC
2023-12-07
BOOMERANG
BOOMERANG
98085253 not registered Live/Pending
Boomerang Intelligence Inc.
2023-07-14
BOOMERANG
BOOMERANG
98082079 not registered Live/Pending
Boomerang Intelligence Inc.
2023-07-12
BOOMERANG
BOOMERANG
98013617 not registered Live/Pending
Boomerang, LLC
2023-05-25
BOOMERANG
BOOMERANG
97976210 not registered Live/Pending
Boomerang Water, LLC
2022-03-17
BOOMERANG
BOOMERANG
97976209 not registered Live/Pending
Boomerang Water, LLC
2022-03-17
BOOMERANG
BOOMERANG
97511488 not registered Live/Pending
BOOMERANGKIT.COM LLC
2022-07-20

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