K200547 is an FDA 510(k) clearance for the Traxcess 14 SELECT Guidewire. This device is classified as a Guide, Wire, Catheter, Neurovasculature (Class II - Special Controls, product code MOF).
Submitted by MicroVention, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on April 16, 2020, 44 days after receiving the submission on March 3, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K200547 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2020 |
| Decision Date | April 16, 2020 |
| Days to Decision | 44 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 |