The following data is part of a premarket notification filed by Micrus Corp. with the FDA for Micrus Microcatheter.
Device ID | K032624 |
510k Number | K032624 |
Device Name: | MICRUS MICROCATHETER |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | MICRUS CORP. 610 PALOMAR AVENUE Mountain View, CA 94085 |
Contact | Margaret Webber |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2003-08-26 |
Decision Date | 2003-09-10 |
Summary: | summary |