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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 K191143
Device Name PowerFlow Implantable Apheresis IV Port
Applicant
C.R. Bard, Inc.
605 N. 5600 W.
Salt Lake Ciy,,  UT  84116
Applicant Contact Kristen Soodak
Correspondent
C.R. Bard, Inc.
605 N. 5600 W.
Salt Lake Ciy,,  UT  84116
Correspondent Contact Kristen Soodak
Regulation Number880.5965
Classification Product Code
PTD  
Date Received04/30/2019
Decision Date 08/02/2019
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
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