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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, Diagnostic
510(k) Number K161287
Device Name DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak
Applicant
Medtronic Vascular
37a Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact Nisarg Shah
Correspondent
Medtronic Vascular
37a Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact Nisarg Shah
Regulation Number870.1200
Classification Product Code
DQO  
Date Received05/09/2016
Decision Date 08/19/2016
Decision Substantially Equivalent - Kit (SESK)
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
Recalls CDRH Recalls
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