Data / Medical devices / United States / Expanse Medical Inc.
Expanse Medical Inc.: FDA-registered device maker in Pleasanton, CA, United States, 3 510(k) clearances
Expanse Medical Inc. is registered with the FDA (registration 3017823876) in Pleasanton, CA, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 20, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017823876
- Address
- 7060Koll Center Parkway, Suite 300, Pleasanton, CA, United States, 94566
- Owner or operator
- Expanse Medical Inc. (10088957)
- Roles
- Manufacturer
- First device listed
- December 9, 2024
- Registered through
- 2026
- Brand names listed
- FLOWRUNNER Aspiration System, FLOWRUNNER Aspiration System 7F, FLOWRUNNER Aspiration System SP 7F
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aspiration Thrombectomy Catheter | QEZ | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Continuous Flush | KRA | 2 | Manufacturer | accessdata.fda.gov |
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | 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 |
|---|---|---|---|---|---|---|
| March 20, 2026 | K254208 | FLOWRUNNER Aspiration System | QEZ | Substantially Equivalent | Expanse Medical, Inc. | accessdata.fda.gov |
| July 14, 2025 | K251488 | FLOWRUNNER Aspiration System | QEZ | Substantially Equivalent | Expanse Medical, Inc. | accessdata.fda.gov |
| April 19, 2024 | K234073 | ICE Aspiration System | QEW | Substantially Equivalent | Expanse Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Aspiration Thrombectomy Catheter
- All makers of Catheter, Continuous Flush
- All makers of Peripheral Mechanical Thrombectomy With Aspiration
Updated March 20, 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.