NeVa PV Thrombectomy Device
FDA 510(k) clearance K253407 · decided 2025-11-24
Clearance details
- K-number
- K253407
- Device name
- NeVa PV Thrombectomy Device
- Applicant
- Vesalio, Inc.
- Decision
- Unknown
- Date received
- 2025-09-30
- Decision date
- 2025-11-24
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- QEX
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MegaVac Mechanical Thrombectomy System (K171493) | Capture Vascular, Inc. | 2017-08-10 |
| INDIGO Aspiration System (K163618) | Penumbra, Inc. | 2017-05-24 |
Recalls involving this device
No recalls on record reference this clearance.