510(k) K253407
- Device
- NeVa PV Thrombectomy Device
- Applicant
- Vesalio, Inc.
- 510(k) number
- K253407
- Product code
- QEX
- Decision
- Unknown (SESU)
- Decision date
- 2025-11-24
- Date received
- 2025-09-30
- Regulation
- 870.5150
- Classification name
- Coronary Mechanical Thrombectomy With Aspiration
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sharon Shachar
- Address
- 2305 Historic Decatur Rd. Suite 100 San Diego CA US 92106 92106
FDA Registration Numbers#
- 2011171
- 1721676
- 3005168196
- 3013758550
- 3016591327
- 3015615738
- 3034619061
- 3014498720