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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, vascular, for promoting embolization
510(k) Number K151358
Device Name AZUR CX Detachable 35 Coils
Applicant
Micro Vention, Inc.
1311 Valencia Avenue
Tustin,  CA  92780
Applicant Contact Cynthia Valenzuela
Correspondent
Micro Vention, Inc.
1311 Valencia Avenue
Tustin,  CA  92780
Correspondent Contact Cynthia Valenzuela
Regulation Number870.3300
Classification Product Code
KRD  
Date Received05/20/2015
Decision Date 09/25/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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