Data / Medical devices / United States / Kaneka Americas Holding Inc
Kaneka Americas Holding Inc: FDA-registered device maker in Newark, CA, United States, 1 510(k) clearance
Kaneka Americas Holding Inc is registered with the FDA (registration 3014758755) in Newark, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 5, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014758755
- Address
- 7979 Gateway Blvd, Newark, CA, United States, 94560
- Owner or operator
- KANEKA AMERICAS HOLDING INC (10095053)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- January 19, 2026
- Registered through
- 2026
- Brand names listed
- Surfrider 13 Microcatheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Continuous Flush | KRA | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Catheter, Percutaneous, Neurovasculature | QJP | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| January 5, 2026 | K251668 | SurfRider 13 Microcatheter | QJP | Substantially Equivalent | Kaneka Americas Holding, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 5, 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.