Data / Medical devices / United States / Embolx Inc.
Embolx Inc.: FDA-registered device maker in Sunnyvale, CA, United States, 3 510(k) clearances
Embolx Inc. is registered with the FDA (registration 3011660785) in Sunnyvale, CA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 23, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011660785
- Address
- 530 Lakeside Dr Ste 150, Sunnyvale, CA, United States, 94085
- Owner or operator
- Embolx Inc. (10049613)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- June 29, 2015
- Registered through
- 2026
- Brand names listed
- Embolx Microcatheter, Soldier Microcatheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular Occluding, Temporary | MJN | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | Complaint file establishment, Manufacturer, 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 |
|---|---|---|---|---|---|---|
| February 23, 2024 | K232536 | Soldier Microcatheter | DQO | Substantially Equivalent | Embolx, Inc. | accessdata.fda.gov |
| June 8, 2018 | K180904 | Sniper Infusion Catheter with Balloon Occlusion | MJN | Substantially Equivalent | Embolx, Inc. | accessdata.fda.gov |
| May 31, 2015 | K142692 | Occlusion Balloon Catheter | MJN | Substantially Equivalent | Embolx, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Intravascular Occluding, Temporary
- All makers of Catheter, Intravascular, Diagnostic
Updated February 23, 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.