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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, intravascular occluding, temporary
510(k) Number K121785
Model BC0410C, BC0415C, BC0420C, BC0411XC
Device Name SCEPTER C OCCLUSION BALLOON CATHETER
Original Applicant
MICRO VENTION, INC.
1311 valencia avenue
tustin,  CA  92780
Original Contact naomi gong
Regulation Number870.4450
Classification Product Code
MJN  
Subsequent Product Code
DQY  
Date Received06/18/2012
Decision Date 08/10/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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