K214024 is an FDA 510(k) clearance for the SOFIA 88 Catheter. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by MicroVention, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on September 12, 2022, 264 days after receiving the submission on December 22, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K214024 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2021 |
| Decision Date | September 12, 2022 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |