Onset Medical Corporation
United StatesFDA applicant, unverified
- Devices
- 26
What Onset Medical Corporation makes
Onset Medical Corporation manufactures balloon-expandable introducers and access systems for vascular and ureteral procedures, including transseptal, transfemoral, and ureteral sheaths. Their products include re-collapsible access systems and expandable sheaths designed for interventional radiology and cardiology applications.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. These products are based in the United States.
Catalogue
Search and filter all 26 devicesCompany details
- DUNS number
- 144431850
- [email protected]
- Phone
- +1(800)283-7866
Frequently asked questions
How many devices does Onset Medical Corporation have in the registry?
The registry currently lists 26 devices for Onset Medical Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Onset Medical Corporation's devices?
Among its 26 most recently registered devices, Onset Medical Corporation has devices listed in FDA 510(k) (8 devices) and FDA GUDID (18 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Onset Medical Corporation's devices fall under?
Among its 26 most recently registered devices, the classes recorded for Onset Medical Corporation's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Onset Medical Corporation in the registry?
The most recently registered devices listed for Onset Medical Corporation include SOLOPATH SR-2035, SOLOPATH STFI-2135, SOLOPATH SR-2235 and SOLOPATH STFI-2125.