The following data is part of a premarket notification filed by Microvention, Inc with the FDA for V-grip Detachment Controller For Use With Hydrocoil Embolic System And Microplex Coil System, Azur Detachment Controller For Use With Azur Peripheral Coil System.
| Device ID | K162999 |
| 510k Number | K162999 |
| Device Name: | V-Grip Detachment Controller For Use With Hydrocoil Embolic System And MicroPlex Coil System, AZUR Detachment Controller For Use With AZUR Peripheral Coil System |
| Classification | Device, Neurovascular Embolization |
| Applicant | MICROVENTION, INC 1311 VALENCIA AVENUE Tustin, CA 92780 |
| Contact | Laraine Pangelina |
| Correspondent | Laraine Pangelina MICROVENTION, INC 1311 VALENCIA AVENUE Tustin, CA 92780 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-28 |
| Decision Date | 2017-03-29 |
| Summary: | summary |