Device Classification Name |
device, neurovascular embolization
|
510(k) Number |
K071246 |
Device Name |
MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR |
Applicant |
MICRUS ENDOVASCULAR CORPORATION |
821 FOX LANE |
SAN JOSE,
CA
95131
|
|
Applicant Contact |
PATRICK LEE |
Correspondent |
MICRUS ENDOVASCULAR CORPORATION |
821 FOX LANE |
SAN JOSE,
CA
95131
|
|
Correspondent Contact |
PATRICK LEE |
Regulation Number | 882.5950
|
Classification Product Code |
|
Date Received | 05/03/2007 |
Decision Date | 06/01/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|