The following data is part of a premarket notification filed by Micrus Endovascular Corporation with the FDA for Micrus Microcoil Delivery System.
Device ID | K082739 |
510k Number | K082739 |
Device Name: | MICRUS MICROCOIL DELIVERY SYSTEM |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-09-18 |
Decision Date | 2008-10-17 |
Summary: | summary |