Xentek Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Xentek Medical, Inc. makes
Xentek Medical, Inc. manufactures urological introducer sheaths and coaxial dilator sets designed for procedural access and dilation in medical settings.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Tearaway Introducer Sheath Ref K000313
Regimes: 510(k) Registry: 510(k)Coaxial Dilator Set Ref K000737
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Xentek Medical, Inc. have in the registry?
The registry currently lists 2 devices for Xentek Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Xentek Medical, Inc.'s devices?
Among its 2 most recently registered devices, Xentek Medical, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Xentek Medical, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Xentek Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Xentek Medical, Inc. in the registry?
The most recently registered devices listed for Xentek Medical, Inc. include TEARAWAY INTRODUCER SHEATH and COAXIAL DILATOR SET.