Data / Medical devices / United States / Flowphysix, Inc.
Flowphysix, Inc.: FDA-registered device maker in West Lake Hills, TX, United States, 1 510(k) clearance
Flowphysix, Inc. is registered with the FDA (registration 3040099838) in West Lake Hills, TX, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 14, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3040099838
- Address
- 1120 S Capital Of Texas Hwy, West Lake Hills, TX, United States, 78746
- Owner or operator
- FlowPhysix, Inc. (10095413)
- Roles
- Specification developer
- First device listed
- March 11, 2026
- Registered through
- 2026
- Brand names listed
- FLOWRUNNER Aspiration System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aspiration Thrombectomy Catheter | QEZ | 2 | Specification developer | accessdata.fda.gov |
| Catheter, Continuous Flush | KRA | 2 | 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 |
|---|---|---|---|---|---|---|
| July 14, 2025 | K251488 | FLOWRUNNER Aspiration System | QEZ | Substantially Equivalent | Expanse Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 14, 2025. 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.