MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF


Device Classification Name

device, neurovascular embolization

510(k) Number K080437
Device Name MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF
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

Correspodent Contact patrick lee
Regulation Number 882.5950
Classification Product Code
HCG  
Date Received 02/15/2008
Decision Date 05/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No