MICRUS ASCENT OCCLUSION BALLOON CATHETER


Device Classification Name

catheter, intravascular occluding, temporary

510(k) Number K080861
Device Name MICRUS ASCENT OCCLUSION BALLOON CATHETER
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 870.4450
Classification Product Code
MJN  
Date Received 03/27/2008
Decision Date 08/27/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No