K213854 is an FDA 510(k) clearance for the SavvyWire. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Opsens, Inc. (Quebec, CA). The FDA issued a Cleared decision on September 14, 2022, 278 days after receiving the submission on December 10, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K213854 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 2021 |
| Decision Date | September 14, 2022 |
| Days to Decision | 278 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQX - Wire, Guide, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1330 |