The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for V-grip Plus Detachment Controller, Model Vg503.
Device ID | K090001 |
510k Number | K090001 |
Device Name: | V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503 |
Classification | Device, Neurovascular Embolization |
Applicant | MICROVENTION, INC. 75 COLUMBIA SUITE A Aliso Viejo, CA 92656 -1408 |
Contact | Naomi Gong |
Correspondent | Naomi Gong MICROVENTION, INC. 75 COLUMBIA SUITE A Aliso Viejo, CA 92656 -1408 |
Product Code | HCG |
CFR Regulation Number | 882.5950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-01-02 |
Decision Date | 2009-03-05 |
Summary: | summary |