The following data is part of a premarket notification filed by Micrus Endovascular Corporation with the FDA for Micrus Microcatheter, Courier Flex, Model Msf 170000-00.
Device ID | K083922 |
510k Number | K083922 |
Device Name: | MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00 |
Classification | Catheter, Intravascular, Diagnostic |
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 | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-12-31 |
Decision Date | 2009-05-06 |
Summary: | summary |