WAVE Medical AG
SwitzerlandFDA applicant, unverified
- Devices
- 1
What WAVE Medical AG makes
WAVE Medical AG manufactures the WAVE PTA Balloon Catheter, a percutaneous transluminal angioplasty (PTA) balloon designed for the dilation of peripheral arteries to treat arterial stenosis or occlusion. The device is intended for use in vascular interventions where mechanical widening of narrowed or blocked vessels is required.
The company’s portfolio is classified under Class II medical devices, with the WAVE PTA Balloon Catheter authorised via the FDA’s 510(k) pathway. The device is listed in the FDA’s 510(k) database, adhering to regulatory standards for peripheral vascular interventions. WAVE Medical AG is headquartered in Switzerland.
Catalogue
WAVE PTA Balloon Catheter Ref K260304
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does WAVE Medical AG have in the registry?
The registry currently lists 1 device for WAVE Medical AG. Devices recorded under merged duplicate company entries are counted once.
Which registries list WAVE Medical AG's devices?
Among its 1 most recently registered device, WAVE Medical AG has devices listed in FDA 510(k) (1 device).
What risk classes do WAVE Medical AG's devices fall under?
Among its 1 most recently registered device, the classes recorded for WAVE Medical AG's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from WAVE Medical AG in the registry?
The most recently registered devices listed for WAVE Medical AG include WAVE PTA Balloon Catheter.