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 |