K251312 is an FDA 510(k) clearance for the Vesalio Peripheral System. This device is classified as a Aspiration Thrombectomy Catheter (Class II - Special Controls, product code QEZ).
Submitted by Vesalio, Inc. (San Diego, US). The FDA issued a Cleared decision on October 24, 2025, 179 days after receiving the submission on April 28, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150. To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration..
| 510(k) Number | K251312 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 2025 |
| Decision Date | October 24, 2025 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QEZ - Aspiration Thrombectomy Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5150 |
| Definition | To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration. |