Data / Medical devices / United States / Endovascular Engineering, Inc.
Endovascular Engineering, Inc.: FDA-registered device maker in Menlo Park, CA, United States, 4 510(k) clearances
Endovascular Engineering, Inc. is registered with the FDA (registration 3026567963) in Menlo Park, CA, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 11, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3026567963
- Address
- 3925 Bohannon Drive Suite 300, Menlo Park, CA, United States, 94025
- Owner or operator
- Endovascular Engineering, Inc. (10087452)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 1, 2023
- Registered through
- 2027
- Brand names listed
- Helo G1 Thrombectomy System, Helo MAX Thrombectomy System, Helo Return, Helo Thrombectomy System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Continuous Flush | KRA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Thrombectomy Whole Blood Return System | SHJ | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| October 11, 2026 | K253717 | Helo Return | SHJ | Substantially Equivalent | Endovascular Engineering, Inc. | accessdata.fda.gov |
| September 3, 2026 | K261800 | Helo Max Thrombectomy System (HEL2090) | QEW | Substantially Equivalent | Endovascular Engineering | accessdata.fda.gov |
| December 18, 2025 | K252956 | Helo Thrombectomy System | QEW | Substantially Equivalent | Endovascular Engineering, Inc. | accessdata.fda.gov |
| February 15, 2023 | K223891 | Cobra Catheter System | QEW | Substantially Equivalent | Endovascular Engineering | accessdata.fda.gov |
Compare with other makers
- All makers of Peripheral Mechanical Thrombectomy With Aspiration
- All makers of Catheter, Continuous Flush
Updated October 11, 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.