K251185 is an FDA 510(k) clearance for the Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020). This device is classified as a Peripheral Mechanical Thrombectomy With Aspiration (Class II - Special Controls, product code QEW).
Submitted by Intervene (Redwood City, US). The FDA issued a Cleared decision on October 22, 2025, 189 days after receiving the submission on April 16, 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 Peripheral Vasculature Through Aspiration..
| 510(k) Number | K251185 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2025 |
| Decision Date | October 22, 2025 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QEW - Peripheral 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 Peripheral Vasculature Through Aspiration. |