K213494 is an FDA 510(k) clearance for the Aveir Retrieval Catheter. This device is classified as a Device, Percutaneous Retrieval (Class II - Special Controls, product code MMX).
Submitted by Abbott Medical (Sylmar, US). The FDA issued a Cleared decision on April 1, 2022, 151 days after receiving the submission on November 1, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150.
| 510(k) Number | K213494 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2021 |
| Decision Date | April 01, 2022 |
| Days to Decision | 151 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MMX — Device, Percutaneous Retrieval |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5150 |