Data / Medical devices / United States / Emboline Inc
Emboline Inc: FDA-registered device maker in Santa Cruz, CA, United States, 1 510(k) clearance
Emboline Inc is registered with the FDA (registration 3044466298) in Santa Cruz, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 8, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3044466298
- Address
- 2901 Mission Street Bldg 2, Santa Cruz, CA, United States, 95060
- Owner or operator
- Emboline (10096334)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- September 10, 2026
- Registered through
- 2026
- Brand names listed
- Emboliner Embolic Protection System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures | PUM | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| September 8, 2026 | K261715 | Emboliner Embolic Protection System (EPC-03) | PUM | Substantially Equivalent | Emboline, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 8, 2026. 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.