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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K252478
Device Name Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port
Applicant
Bard Access Systems, Inc.
605 N. 5600 W.
Salt Lake Ciy,,  UT  84116
Applicant Contact Kaitlyn Nielsen
Correspondent
Bard Access Systems, Inc.
605 N. 5600 W.
Salt Lake Ciy,,  UT  84116
Correspondent Contact Kaitlyn Nielsen
Regulation Number880.5965
Classification Product Code
LJT  
Date Received08/07/2025
Decision Date 09/05/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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