The following data is part of a premarket notification filed by Micrus Corp. with the FDA for Micrus Stretch-resistant Microcoil System, Msr01.
Device ID | K022420 |
510k Number | K022420 |
Device Name: | MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01 |
Classification | Device, Neurovascular Embolization |
Applicant | MICRUS CORP. 495 CLYDE AVE. Mountain View, CA 94043 |
Contact | Margaret Webber |
Correspondent | Margaret Webber MICRUS CORP. 495 CLYDE AVE. Mountain View, CA 94043 |
Product Code | HCG |
CFR Regulation Number | 882.5950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-07-24 |
Decision Date | 2002-10-22 |