Alseal
Country not established
- Devices
- 3
What Alseal makes
Alseal manufactures vascular access products, including the HQS Introducer (Model 2064-HQS) and the XCATH, designed for catheter insertion and secure vascular access. These devices are intended for use in medical procedures requiring reliable puncture and sheath placement.
The company’s portfolio is regulated under FDA Class II devices, with products authorised via the 510(k) clearance pathway. These devices are listed in the FDA’s 510(k) registry, and the company operates from the United States.
Catalogue
HQS Introducer (Model 2064-HQS) Ref K153494
Regimes: 510(k) Registry: 510(k)Xcath Ref K133296
Regimes: 510(k) Registry: 510(k)Hqs Introducer Ref K113849
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Alseal have in the registry?
The registry currently lists 3 devices for Alseal. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alseal's devices?
Among its 3 most recently registered devices, Alseal has devices listed in FDA 510(k) (3 devices).
What risk classes do Alseal's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Alseal's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Alseal in the registry?
The most recently registered devices listed for Alseal include HQS Introducer (Model 2064-HQS), XCATH and HQS INTRODUCER.