The following data is part of a premarket notification filed by Micrus Corp. with the FDA for Micrus Microcoil Delivery System, Mds03.
Device ID | K002056 |
510k Number | K002056 |
Device Name: | MICRUS MICROCOIL DELIVERY SYSTEM, MDS03 |
Classification | Device, Neurovascular Embolization |
Applicant | MICRUS CORP. 495 CLYDE AVE. Mountain View, CA 94043 |
Contact | Tom Holdych |
Correspondent | Tom Holdych 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 | 2000-07-06 |
Decision Date | 2001-01-11 |