The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Traxcess 7 Mini Xsoft Guidewire.
| Device ID | K163154 |
| 510k Number | K163154 |
| Device Name: | Traxcess 7 Mini XSoft Guidewire |
| Classification | Guide, Wire, Catheter, Neurovasculature |
| Applicant | MicroVention, Inc. 1311 Valencia Avenue Tustin, CA 92780 |
| Contact | Sapna Singh |
| Correspondent | Sapna Singh MicroVention, Inc. 1311 Valencia Avenue Tustin, CA 92780 |
| Product Code | MOF |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-10 |
| Decision Date | 2016-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816777025500 | K163154 | 000 |