K093397 is an FDA 510(k) clearance for the TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by MicroVention, Inc. (Tistin, US). The FDA issued a Cleared decision on December 17, 2009, 48 days after receiving the submission on October 30, 2009.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K093397 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2009 |
| Decision Date | December 17, 2009 |
| Days to Decision | 48 days |
| Submission Type | Special |
| 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 |