aveeramedical.comBoomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)
Aveera Medical, Inc.
AVEERA MEDICAL
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3027735872 | 3027735872 | AVEERA MEDICAL | 1 | N | 2026-01-01 | 929 Calle Negocio Ste A San Clemente CA US 92673 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00860013182304 | Boomerang - 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. | 4405671793 | cchapek@aveeramedical.com |
| 00860013182311 | Boomerang - 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. | 4405671793 | cchapek@aveeramedical.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission |
|---|---|---|
| 341685 | 1918464414 | K250105 |
PMN#
GUDID#
Boomerang - 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.
2025-07-14
Boomerang - 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.
2025-07-14