Data / Medical devices / United States / Protexa Endovascular
Protexa Endovascular: FDA-registered device maker in Grand Junction, CO, United States, 1 510(k) clearance
Protexa Endovascular is registered with the FDA (registration 3034619061) in Grand Junction, CO, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 10, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3034619061
- Address
- 1556 Wellington Avenue, Grand Junction, CO, United States, 81501
- Owner or operator
- Protexa Endovascular (10092300)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 20, 2024
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coronary Mechanical Thrombectomy With Aspiration | QEX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | 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 |
|---|---|---|---|---|---|---|
| August 10, 2017 | K171493 | MegaVac Mechanical Thrombectomy System | QEX | Substantially Equivalent | Capture Vascular, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Peripheral Mechanical Thrombectomy With Aspiration
- All makers of Coronary Mechanical Thrombectomy With Aspiration
Updated August 10, 2017. 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.