Data / Medical devices / United States / Embolization Inc
Embolization Inc: FDA-registered device maker in Boulder, CO, United States, 1 510(k) clearance
Embolization Inc is registered with the FDA (registration 3042953152) in Boulder, CO, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 15, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042953152
- Address
- 5421 Western Ave, Boulder, CO, United States, 80301
- Owner or operator
- Boulder iQ (10094690)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 16, 2025
- Registered through
- 2026
- Brand names listed
- Nitinol Enhanced Device (NED)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Vascular, For Promoting Embolization | KRD | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 15, 2025 | K250276 | Nitinol Enhanced Device (NED) | KRD | Substantially Equivalent | Embolization, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 15, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.