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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K113133
Device Name MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE
Applicant
Medrad, Inc.
One Medrad Dr.
Indianola,  PA  15051
Applicant Contact MIKE BURNSIDE
Correspondent
Medrad, Inc.
One Medrad Dr.
Indianola,  PA  15051
Correspondent Contact MIKE BURNSIDE
Regulation Number870.1650
Classification Product Code
DXT  
Date Received10/24/2011
Decision Date 12/15/2011
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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