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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peripheral, Atherectomy
510(k) Number K131092
Device Name STEALTH 360 ORBITAL PAD SYSTEM
Applicant
Cardio Systems, Inc.
651 Campus Dr.
Saint Paul,  MN  55112
Applicant Contact MAUREEN MCDONNELL
Correspondent
Cardio Systems, Inc.
651 Campus Dr.
Saint Paul,  MN  55112
Correspondent Contact MAUREEN MCDONNELL
Regulation Number870.4875
Classification Product Code
MCW  
Date Received04/18/2013
Decision Date 06/24/2013
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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