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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Percutaneous Retrieval
510(k) Number K133681
Device Name CRUX SNARE FILTER RETRIEVAL SET
Applicant
Volcano Corporation
1 Fortune Dr.
Billerica,  MA  01821
Applicant Contact ELISA HEBB
Correspondent
Volcano Corporation
1 Fortune Dr.
Billerica,  MA  01821
Correspondent Contact ELISA HEBB
Regulation Number870.5150
Classification Product Code
MMX  
Date Received12/02/2013
Decision Date 01/30/2014
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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