The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Traxcess .007 Mini Guidewire.
| Device ID | K161803 |
| 510k Number | K161803 |
| Device Name: | Traxcess .007 Mini 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 | 2016-06-30 |
| Decision Date | 2016-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816777025494 | K161803 | 000 |