Realize Medical, Inc.
CanadaFDA 510(k) applicant, unverified FDA
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Realize Medical, Inc. makes
Realize Medical, Inc. manufactures the Elucis, a medical device designed for percutaneous coronary intervention (PCI) procedures, including chronic total occlusion (CTO) crossings and complex coronary artery cases.
The Elucis is classified as a Class II device under FDA regulations and is authorised via the 510(k) clearance process. The company is based in the United States.
Catalogue
- GUDID
Elucis Ref K220649
510(k) 510(k)
Company details
- DUNS number
- 204914249
FDA establishments
- Realize Medical Inc. Ottawa Ontario · CA FEI 3021163566
Frequently asked questions
How many devices does Realize Medical, Inc. have in the registry?
The registry currently lists 2 devices for Realize Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Realize Medical, Inc.'s devices?
Among its 2 most recently registered devices, Realize Medical, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Realize Medical, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Realize Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Realize Medical, Inc. in the registry?
The most recently registered devices listed for Realize Medical, Inc. include Elucis 1.7 and Elucis.
Which FDA establishments are linked to Realize Medical, Inc.?
1 FDA establishment is linked to Realize Medical, Inc. in the registry; they are listed on the company page.