Data / Medical devices / United States / Nuvascular Inc.
Nuvascular Inc.: FDA-registered device maker in Irvine, CA, United States, 1 510(k) clearance
Nuvascular Inc. is registered with the FDA (registration 3030003849) in Irvine, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 9, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3030003849
- Address
- 141 Innovation Dr Ste 100, Irvine, CA, United States, 92617
- Owner or operator
- Nuvascular Inc. (10091454)
- Roles
- Manufacturer
- First device listed
- July 10, 2025
- Registered through
- 2027
- Brand names listed
- HARBOR Occlusion Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Vascular, For Promoting Embolization | KRD | 2 | 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 |
|---|---|---|---|---|---|---|
| July 9, 2025 | K250133 | HARBOR Occlusion Device | KRD | Substantially Equivalent | Nuvascular, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 9, 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.