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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 K181836
Device Name 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters
Applicant
Cordis, A Cardinal Health Company
1820 Mccarthy Blvd.
Milpitas,  CA  95035
Applicant Contact Vidya Venkataeaghavan
Correspondent
Cordis, A Cardinal Health Company
1820 Mccarthy Blvd.
Milpitas,  CA  95035
Correspondent Contact Vidya Venkataeaghavan
Regulation Number870.1200
Classification Product Code
DQO  
Date Received07/10/2018
Decision Date 08/08/2018
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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