Embolization, Inc.
Country not established
- Devices
- 6
What Embolization, Inc. makes
Embolization, Inc. manufactures the Nitinol Enhanced Device (NED), a vascular embolization product designed for targeted occlusion in interventional radiology procedures.
The NED is classified as a Class II medical device under FDA regulations and is authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Nitinol Enhanced Device (NED) Ref K250276
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 144855401
- [email protected]
- Phone
- 303-531-1238
Frequently asked questions
How many devices does Embolization, Inc. have in the registry?
The registry currently lists 6 devices for Embolization, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Embolization, Inc.'s devices?
Among its 6 most recently registered devices, Embolization, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (5 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Embolization, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Embolization, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Embolization, Inc. in the registry?
The most recently registered devices listed for Embolization, Inc. include Nitinol Enhanced Device N3F-3400, Nitinol Enhanced Device N3F-4500, Nitinol Enhanced Device N3P-0035 and Nitinol Enhanced Device N3F-2300.