K133725 is an FDA 510(k) clearance for the TRAXCESS 14 GUIDEWIRE. This device is classified as a Guide, Wire, Catheter, Neurovasculature (Class II - Special Controls, product code MOF).
Submitted by MicroVention, Inc. (Tistin, US). The FDA issued a Cleared decision on July 31, 2014, 237 days after receiving the submission on December 6, 2013.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K133725 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2013 |
| Decision Date | July 31, 2014 |
| Days to Decision | 237 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 |