The following data is part of a premarket notification filed by Micro Vention Inc. with the FDA for Traxcess 7 Mini Guidewire.
Device ID | K201487 |
510k Number | K201487 |
Device Name: | Traxcess 7 Mini Guidewire |
Classification | Guide, Wire, Catheter, Neurovasculature |
Applicant | Micro Vention Inc. 35 Enterprise Aliso Viejo, CA 92656 |
Contact | Ganesh Balachandar |
Correspondent | Ganesh Balachandar Micro Vention 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 | 2020-06-04 |
Decision Date | 2020-07-02 |