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510(k) K242328

PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports by Bard Access Systems, Inc. — Product Code LJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2024
Date Received
August 6, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class
Class II
Regulation Number
880.5965
Review Panel
HO
Submission Type

Other clearances by Bard Access Systems, Inc.

  • K252478 — Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Inj (September 5, 2025)
  • K251253 — PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M. (June 18, 2025)
  • K241353 — PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set (November 27, 2024)
  • K240146 — BD Prevue™ II Peripheral Vascular Access System (February 18, 2024)
  • K223198 — BD Intraosseous Vascular Access System EMS Powered Driver (D001003) (November 10, 2022)
  • K222232 — Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly (August 24, 2022)
  • K210264 — BD PowerPiCC Catheter (July 30, 2021)
  • K120882 — SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE (May 30, 2012)
  • K100402 — SITE-RITE VISION ULTRASOUND SYSTEM (March 5, 2010)
  • K071095 — ASPIRA PLEURAL DRAINAGE SYSTEM (May 18, 2007)

Other clearances for product code LJT

  • K252478 — Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Inj (September 5, 2025)
  • K251253 — PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M. (June 18, 2025)
  • K232737 — PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp (December 8, 2023)
  • K190559 — SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports (May 22, 2020)
  • K181446 — Bard Power-Injectable Implantable Ports (PowerPorts®) (July 8, 2019)
  • K151239 — NMI DUAL PORT II (June 6, 2016)
  • K153359 — BardPort®, SlimPort®, and X-Port® Implanted Ports (May 20, 2016)
  • K153238 — Dignity Dual Port (March 15, 2016)
  • K153228 — NMI Port, NMI Port II (December 4, 2015)
  • K150514 — Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters (November 20, 2015)