pVasc Net Mechanical Thrombectomy Device
FDA 510(k) clearance K254211 · decided 2026-08-05
Clearance details
- K-number
- K254211
- Device name
- pVasc Net Mechanical Thrombectomy Device
- Applicant
- Vesalio, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-12-29
- Decision date
- 2026-08-05
- Days to decision
- 219 days
- Clearance type
- Special
- Advisory committee
- Unknown
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.