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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter For Crossing Total Occlusions
510(k) Number K161208
Device Name CROSSER CTO Recanalization Catheter
Applicant
Bard Peripheral Vacular, Inc.
1625 West 3rd Street
Tempe,  AZ  85281
Applicant Contact Melanie Hadlock
Correspondent
Bard Peripheral Vacular, Inc.
1625 West 3rd Street
Tempe,  AZ  85281
Correspondent Contact Melanie Hadlock
Regulation Number870.1250
Classification Product Code
PDU  
Date Received04/28/2016
Decision Date 05/24/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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