K213771 is an FDA 510(k) clearance for the Merlin Aspiration System. This device is classified as a Catheter, Embolectomy (Class II - Special Controls, product code DXE).
Submitted by Mivi Neurovascular, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on January 27, 2022, 56 days after receiving the submission on December 2, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150.
| 510(k) Number | K213771 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2021 |
| Decision Date | January 27, 2022 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXE - Catheter, Embolectomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5150 |