The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Microplex Coil System (mcs) And Hydrocoil Embolic System (hes) With The Hydrolink Syringe Kit.
| Device ID | K022735 |
| 510k Number | K022735 |
| Device Name: | MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT |
| Classification | Device, Neurovascular Embolization |
| Applicant | MICROVENTION, INC. 72 ARGONAUT Aliso Viejo, CA 92656 -1408 |
| Contact | Vincent Cutaurelli |
| Correspondent | Vincent Cutaurelli MICROVENTION, INC. 72 ARGONAUT 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 | 2002-08-19 |
| Decision Date | 2002-09-06 |
| Summary: | summary |