MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO


Device Classification Name

catheter, intravascular occluding, temporary

510(k) Number K103780
Device Name MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO
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 12/27/2010
Decision Date 01/26/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No