Xtrak Medical, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 3
What Xtrak Medical, Inc. makes
Xtrak Medical, Inc. manufactures mechanical thrombectomy systems, including thrombectomy catheters, control consoles, and collection bottles designed for the removal of blood clots in vascular procedures. The portfolio also includes support catheters for guiding and stabilizing catheter placement during interventions.
The company’s devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The products are intended for use in the United States, where regulatory compliance is required for market authorisation.
Catalogue
- 510(k) 510(k)
Xtrak Support Catheter Ref K032660
510(k) 510(k)Xtd Thrombectomy Catheter, Xx Cm Ref K021641
510(k) 510(k)
Frequently asked questions
How many devices does Xtrak Medical, Inc. have in the registry?
The registry currently lists 3 devices for Xtrak Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Xtrak Medical, Inc.'s devices?
Among its 3 most recently registered devices, Xtrak Medical, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Xtrak Medical, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Xtrak Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Xtrak Medical, Inc. in the registry?
The most recently registered devices listed for Xtrak Medical, Inc. include XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL, XTRAK SUPPORT CATHETER and XTD THROMBECTOMY CATHETER, XX CM.