FDA.reportPublic FDA data

Boomerang

Primary DI
00860013182304
Brand
Boomerang
Company
Aveera Medical Inc.
Model
BMGVT080
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.
Published
2025-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MGZValvulotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGZValvulotomeCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250105000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250105000Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)Aveera Medical, Inc.2025-07-03MGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013182304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013182304008600131823048600131823040860013182304

GMDN Terms#

Term, Definition table
TermDefinition
Valvulotome, percutaneousA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge4French
Catheter Working Length80Centimeter
Guidewire Diameter0.018Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4405671793cchapek@aveeramedical.com

Regulatory Flags#

DUNS number
119410497
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013182311BoomerangBMGPVT1252025-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013182311BoomerangAveera Medical Inc.MGZ2025-07-14
00850041730134LimFlow VectorInari Medical, Inc.MGZ2024-04-12
00850041730028LimFlow VectorInari Medical, Inc.MGZ2023-06-26
00840663102297Eze-Sit Valvulotome Lemaitre Vascular, Inc.MGZ2022-06-30
H862TIVCNC0Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-17
H862TIVH20NC0Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-17
H862TIVH30NC0Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-17
H862TIVCNC2Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-17
H862TIVH20NC2Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-17
H862TIVH30NC2Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-17
H862TIVH40NC0Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-11
H862TIVK2030NC0Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-11
H862TIVK2030NC2Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-11
H862TIVH40NC2Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-11
00887482049938Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.MGZ2018-09-25
00887482049945Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.MGZ2018-09-25
00887482049952Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.MGZ2018-09-25
00887482049969Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.MGZ2018-09-25
00887482090282Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.MGZ2018-09-25
00887482090299Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.MGZ2018-09-25
M944AL103110Wexler Surgical, Inc.WEXLER SURGICAL, INC.MGZ2016-12-20
M944AL103010Wexler Surgical, Inc.WEXLER SURGICAL, INC.MGZ2016-12-19
04057034015308Valvulotome 25cm, blade 2mm, w/ballGeister Medizintechnik GmbHMGZ2016-09-21
04057034015322Valvulotome 23cm, blade 2mm, w/ballGeister Medizintechnik GmbHMGZ2016-09-21
00846159010978SCANLAN® In Situ Valvulotomes SCANLAN INTERNATIONAL INCMGZ2016-09-02
00846159010985SCANLAN® In Situ Valvulotomes SCANLAN INTERNATIONAL INCMGZ2016-09-02
00846159010992SCANLAN® In Situ Valvulotomes SCANLAN INTERNATIONAL INCMGZ2016-09-02
00846159031997SCANLAN® In Situ Valvulotomes SCANLAN INTERNATIONAL INCMGZ2016-09-02
00846159032000SCANLAN® In Situ Valvulotomes SCANLAN INTERNATIONAL INCMGZ2016-09-02
H862TIVC0Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2016-08-31