The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Traxcess 14 Guidewire.
| Device ID | K133725 |
| 510k Number | K133725 |
| Device Name: | TRAXCESS 14 GUIDEWIRE |
| Classification | Guide, Wire, Catheter, Neurovasculature |
| Applicant | MICROVENTION, INC. 1311 VALENCIA AVE Tustin, CA 92780 |
| Contact | Naomi Gong |
| Correspondent | Naomi Gong MICROVENTION, INC. 1311 VALENCIA AVE Tustin, CA 92780 |
| Product Code | MOF |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-06 |
| Decision Date | 2014-07-31 |
| Summary: | summary |