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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K860161
Device Name HEART CATHETERIZATION TRAY
Applicant
Medical Design Concepts, Inc.
5741 Palmer Way
Carlsbad,  CA  92008
Applicant Contact RONALD BERTANZI
Correspondent
Medical Design Concepts, Inc.
5741 Palmer Way
Carlsbad,  CA  92008
Correspondent Contact RONALD BERTANZI
Regulation Number870.1310
Classification Product Code
DRE  
Date Received01/16/1986
Decision Date 05/02/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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