Device Classification Name |
wire, guide, catheter
|
510(k) Number |
K053265 |
Device Name |
MICRUS GUIDE WIRE, WATUSI 0.014 |
Applicant |
MICRUS ENDOVASCULAR CORPORATION |
610 PALOMAR AVENUE |
SUNNYVALE,
CA
94085
|
|
Applicant Contact |
MARGARET WEBBER |
Correspondent |
MICRUS ENDOVASCULAR CORPORATION |
610 PALOMAR AVENUE |
SUNNYVALE,
CA
94085
|
|
Correspondent Contact |
MARGARET WEBBER |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 11/22/2005 |
Decision Date | 04/28/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|