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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Subcutaneous Implanted Apheresis Port
510(k) Number K163001
Device Name PowerFlow Apheresis I.V. Port
Applicant
C.R. Bard, Inc.
605 N. 5600 W.
Salt Lake Ciy,,  UT  84116
Applicant Contact Christoph Wagner von Hoff
Correspondent
C.R. Bard, Inc.
605 N. 5600 W.
Salt Lake Ciy,,  UT  84116
Correspondent Contact Christoph Wagner Von Hoff
Regulation Number880.5965
Classification Product Code
PTD  
Date Received10/28/2016
Decision Date 04/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
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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