The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Microplex Coil System (mcs) - Hypersoft 3d.
| Device ID | K161452 |
| 510k Number | K161452 |
| Device Name: | MicroPlex Coil System (MCS) - HyperSoft 3D |
| Classification | Device, Neurovascular Embolization |
| Applicant | MICROVENTION, INC. 1311 VALENCIA AVENUE Tustin, CA 92780 |
| Contact | Sapna Singh |
| Correspondent | Sapna Singh MICROVENTION, INC. 1311 VALENCIA AVENUE Tustin, CA 92780 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-26 |
| Decision Date | 2016-08-31 |
| Summary: | summary |