Qualimed USA, LLC
Country not established
- Devices
- 1
What Qualimed USA, LLC makes
Qualimed USA, LLC manufactures percutaneous transluminal angioplasty (PTA) balloon catheters, including models designed for peripheral vascular applications (PVQ) and mitral valve interventions (MIT). These devices are intended for use in vascular procedures to dilate narrowed or obstructed arteries and veins.
The company’s PTA balloon catheters are classified as Class II devices under FDA regulations and are listed via 510(k) clearance. The products are intended for use in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Qualimed USA, LLC have in the registry?
The registry currently lists 1 device for Qualimed USA, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Qualimed USA, LLC's devices?
Among its 1 most recently registered device, Qualimed USA, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Qualimed USA, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Qualimed USA, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Qualimed USA, LLC in the registry?
The most recently registered devices listed for Qualimed USA, LLC include PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ).