K222690 is an FDA 510(k) clearance for the SmartGUIDE deflectable hydrophilic guidewire. This device is classified as a Guide, Wire, Catheter, Neurovasculature (Class II - Special Controls, product code MOF).
Submitted by Artiria Medical SA (Geneva, CH). The FDA issued a Cleared decision on April 24, 2023, 230 days after receiving the submission on September 6, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K222690 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 2022 |
| Decision Date | April 24, 2023 |
| Days to Decision | 230 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | MOF - Guide, Wire, Catheter, Neurovasculature |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1330 |