510(k) clearance
Helo Max Thrombectomy System (HEL2090)
- 510(k) number
- K261800
- Applicant
- Endovascular Engineering
- Decision date
- Sep 3, 2026
- Date received
- Jun 1, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QEW
- Device type
- Peripheral Mechanical Thrombectomy With Aspiration
- Device class
- Class II
- Regulation
- 21 CFR 870.5150
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Menlo Park, CA, US