The following data is part of a premarket notification filed by Microvention Inc. with the FDA for Traxcess 14 Select Guidewire.
| Device ID | K200547 |
| 510k Number | K200547 |
| Device Name: | Traxcess 14 SELECT Guidewire |
| Classification | Guide, Wire, Catheter, Neurovasculature |
| Applicant | MicroVention Inc. 35 Enterprise Aliso Viejo, CA 92656 |
| Contact | Ganesh Balachandar |
| Correspondent | Ganesh Balachandar MicroVention Inc. 35 Enterprise Aliso Viejo, CA 92656 |
| Product Code | MOF |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-03 |
| Decision Date | 2020-04-16 |