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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Intravascular, Cardiovascular
510(k) Number K120402
Device Name CRUX VENA CAVA FILTER SYSTEM
Applicant
Crux Biomedical
1455 Adams Dr., #1170
Menlo Park,  CA  94025
Applicant Contact ELISA HEBB
Correspondent
Crux Biomedical
1455 Adams Dr., #1170
Menlo Park,  CA  94025
Correspondent Contact ELISA HEBB
Regulation Number870.3375
Classification Product Code
DTK  
Date Received02/08/2012
Decision Date 07/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT01120509
NCT01120522
NCT01120535
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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