Data / Medical devices / United States / Elumn8 Medical, Inc
Elumn8 Medical, Inc: FDA-registered device maker in Campbell, CA, United States, 1 510(k) clearance
Elumn8 Medical, Inc is registered with the FDA (registration 3020677060) in Campbell, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 19, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3020677060
- Address
- 747 Camden Ave Ste E, Campbell, CA, United States, 95008
- Owner or operator
- Elumn8 Medical, Inc (10092638)
- Roles
- Manufacturer
- First device listed
- January 30, 2025
- Registered through
- 2026
- Brand names listed
- Shadow Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Percutaneous | DQY | 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 |
|---|---|---|---|---|---|---|
| December 19, 2024 | K240885 | Shadow Catheter | DQY | Substantially Equivalent | Simpson Interventions, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 19, 2024. 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.