K230494 is an FDA 510(k) clearance for the ClotTriever BOLD Catheter. This device is classified as a Peripheral Mechanical Thrombectomy With Aspiration (Class II - Special Controls, product code QEW).
Submitted by Inari Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on April 18, 2023, 54 days after receiving the submission on February 23, 2023.
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 | K230494 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2023 |
| Decision Date | April 18, 2023 |
| Days to Decision | 54 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. |