K220398 is an FDA 510(k) clearance for the Aristotle 14 Guidewire. This device is classified as a Guide, Wire, Catheter, Neurovasculature (Class II - Special Controls, product code MOF).
Submitted by Scientia Vascular, LLC (West Valley City, US). The FDA issued a Cleared decision on March 10, 2023, 392 days after receiving the submission on February 11, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K220398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2022 |
| Decision Date | March 10, 2023 |
| Days to Decision | 392 days |
| Submission Type | Special |
| 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 |