The following data is part of a premarket notification filed by Micrus Endovascular Corporation with the FDA for Micrus Microcoil System Presidio-18, Model Pc4.
| Device ID | K062036 |
| 510k Number | K062036 |
| Device Name: | MICRUS MICROCOIL SYSTEM PRESIDIO-18, MODEL PC4 |
| Classification | Device, Neurovascular Embolization |
| Applicant | MICRUS ENDOVASCULAR CORPORATION 821 FOX LANE San Jose, CA 95131 |
| Contact | Patrick Lee |
| Correspondent | Patrick Lee MICRUS ENDOVASCULAR CORPORATION 821 FOX LANE San Jose, CA 95131 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-19 |
| Decision Date | 2006-08-25 |
| Summary: | summary |