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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 K110741
Device Name SCEPTER C OCCLUSION BALLOON CATHETER
Applicant
MicroVention, Inc.
1311 Valencia Ave.
Tistin,  CA  92780
Applicant Contact Naomi Gong
Correspondent
MicroVention, Inc.
1311 Valencia Ave.
Tistin,  CA  92780
Correspondent Contact Naomi Gong
Regulation Number870.4450
Classification Product Code
MJN  
Date Received03/16/2011
Decision Date 09/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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