The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Traxcess Pro 14 Guidewire.
| Device ID | K153053 |
| 510k Number | K153053 |
| Device Name: | Traxcess Pro 14 Guidewire |
| Classification | Guide, Wire, Catheter, Neurovasculature |
| Applicant | MICROVENTION, INC. 1311 VALENCIA AVENUE Tustin, CA 72780 |
| Contact | Sapna Singh |
| Correspondent | Sapna Singh MICROVENTION, INC. 1311 VALENCIA AVENUE Tustin, CA 72780 |
| Product Code | MOF |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-20 |
| Decision Date | 2015-12-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812636022260 | K153053 | 000 |