K213402 is an FDA 510(k) clearance for the Triever24, Triever20. This device is classified as a Peripheral Mechanical Thrombectomy With Aspiration (Class II - Special Controls, product code QEW).
Submitted by Inari Medical (Irvine, US). The FDA issued a Cleared decision on May 23, 2022, 217 days after receiving the submission on October 18, 2021.
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 | K213402 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 2021 |
| Decision Date | May 23, 2022 |
| Days to Decision | 217 days |
| Submission Type | Special |
| 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. |