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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 K143538
Device Name MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit
Applicant
Bayer Medical Care, Inc.
1 Bayer Dr.
Indianaola,  PA  15051
Applicant Contact LISA A. EWING
Correspondent
Bayer Medical Care, Inc.
1 Bayer Dr.
Indianaola,  PA  15051
Correspondent Contact LISA A. EWING
Regulation Number870.1650
Classification Product Code
DXT  
Date Received12/15/2014
Decision Date 08/14/2015
Decision Substantially Equivalent (SESE)
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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