The following data is part of a premarket notification filed by Micrus Endovascular Corporation with the FDA for Micrus Courier Enzo Microcatheter 0.017.
Device ID | K070456 |
510k Number | K070456 |
Device Name: | MICRUS COURIER ENZO MICROCATHETER 0.017 |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | MICRUS ENDOVASCULAR CORPORATION 821 FOX LANE San Jose, CA 95131 |
Contact | R. Michael Crompton |
Correspondent | R. Michael Crompton 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 | 2007-02-16 |
Decision Date | 2007-05-24 |
Summary: | summary |