Walk Vascular, LLC
United StatesFDA applicant, unverified
- Devices
- 9
What Walk Vascular, LLC makes
Walk Vascular, LLC manufactures peripheral thrombectomy systems designed to remove clots from veins and arteries in the legs and arms. These include mechanical thrombectomy devices such as the JETi AIO, JETi 88, and ClearLumen II, which use rotational or aspiration techniques to clear blockages in peripheral blood vessels.
The company’s devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. All products are listed in the FDA’s 510(k) database, reflecting their regulatory clearance for peripheral thrombectomy applications. The company is based in the United States.
Catalogue
JETi AIO Peripheral Thrombectomy System Ref K213565
Regimes: 510(k) Registry: 510(k)Clearlumen Thrombectomy System Ref K140296
Regimes: 510(k) Registry: 510(k)Clearlumen Thrombectomy System Ref K120508
Regimes: 510(k) Registry: 510(k)JETi AIO Peripheral Thrombectomy System Ref K201998
Regimes: 510(k) Registry: 510(k)ClearLumen II Peripheral Thrombectomy System Ref K163051
Regimes: 510(k) Registry: 510(k)ClearLumen II Peripheral Thrombectomy System Ref K172000
Regimes: 510(k) Registry: 510(k)JETi 88 Peripheral Thrombectomy System Ref K183403
Regimes: 510(k) Registry: 510(k)ClearLumen II Thrombectomy System Ref K161786
Regimes: 510(k) Registry: 510(k)JETi Peripheral Thrombectomy System Ref K192439
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Walk Vascular, LLC have in the registry?
The registry currently lists 9 devices for Walk Vascular, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Walk Vascular, LLC's devices?
Among its 9 most recently registered devices, Walk Vascular, LLC has devices listed in FDA 510(k) (9 devices).
What risk classes do Walk Vascular, LLC's devices fall under?
Among its 9 most recently registered devices, the classes recorded for Walk Vascular, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Walk Vascular, LLC in the registry?
The most recently registered devices listed for Walk Vascular, LLC include JETi AIO Peripheral Thrombectomy System, CLEARLUMEN THROMBECTOMY SYSTEM, ClearLumen II Peripheral Thrombectomy System and JETi 88 Peripheral Thrombectomy System.