Home / 510(k) Clearances / K150514

510(k) K150514

Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters by C.R. Bard, Inc. — Product Code LJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2015
Date Received
February 27, 2015
Clearance Type
Traditional
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 C.R. Bard, Inc.

  • K251864 — Rubber Utility Catheter (February 23, 2026)
  • K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) (May 15, 2025)
  • K241334 — Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Elec (January 31, 2025)
  • K230356 — Aspirex™ Thrombectomy System (March 31, 2023)
  • K223177 — Highlander™ 014 PTA Balloon Dilatation Catheter (January 20, 2023)
  • K222793 — WavelinQ™ Generator (October 17, 2022)
  • K220270 — Aspirex Thrombectomy System (June 21, 2022)
  • K213203 — Provena(TM) Midline Catheter (May 13, 2022)
  • K212588 — Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PT (May 4, 2022)
  • K212708 — Halo One Thin-Walled Guiding Sheath (September 23, 2021)

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)
  • K242328 — PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implan (October 31, 2024)
  • 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)