The following data is part of a premarket notification filed by Micrus Endovascular Corporation with the FDA for Micrus Courier Microcatheters.
Device ID | K060116 |
510k Number | K060116 |
Device Name: | MICRUS COURIER MICROCATHETERS |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | MICRUS ENDOVASCULAR CORPORATION 821 FOX LANE San Jose, CA 95131 |
Contact | Margaret Webber |
Correspondent | Margaret Webber MICRUS ENDOVASCULAR CORPORATION 821 FOX LANE San Jose, CA 95131 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-01-17 |
Decision Date | 2006-05-12 |
Summary: | summary |