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510(k) K153238

Dignity Dual Port by Medcomp ( Medical Components) — Product Code LJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2016
Date Received
November 9, 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 Medcomp ( Medical Components)

  • K162389 — Medcomp Vessel Dilator (June 1, 2017)
  • K143238 — C3 Wave (April 24, 2015)
  • K132177 — MEDCOMP GEN III POWER INJECTABLE PORT (December 12, 2013)
  • K130897 — MEDCOMP VASCU-PICC WITH VALVE (October 22, 2013)
  • K110424 — DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROF (November 30, 2011)
  • K093309 — PRO-LINE CT (BASIC TRAY) MODEL MR28036101 (November 24, 2009)

Other clearances for product code LJT

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  • 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)
  • K153228 — NMI Port, NMI Port II (December 4, 2015)
  • K150514 — Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters (November 20, 2015)