K253407 is an FDA 510(k) clearance for the NeVa PV Thrombectomy Device. This device is classified as a Coronary Mechanical Thrombectomy With Aspiration (Class II - Special Controls, product code QEX).
Submitted by Vesalio, Inc. (San Diego, US). The FDA issued a Cleared decision on November 24, 2025, 55 days after receiving the submission on September 30, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150. To Mechanically Disrupt Thrombus And/or Debris Prior To Removal From The Coronary Vasculature Through Aspiration..
| 510(k) Number | K253407 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | September 30, 2025 |
| Decision Date | November 24, 2025 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QEX - Coronary Mechanical Thrombectomy With Aspiration |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5150 |
| Definition | To Mechanically Disrupt Thrombus And/or Debris Prior To Removal From The Coronary Vasculature Through Aspiration. |