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510(k) K854019

PORT-GARD by Cormed, Inc., Sub. C.R.Bard, Inc. — Product Code LJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 1985
Date Received
September 30, 1985
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 Cormed, Inc., Sub. C.R.Bard, Inc.

  • K863606 — BUTTERFLY NON-CORING NEEDLE SET (December 18, 1986)
  • K860432 — PERCUTANEOUS INTRODUCER KIT (March 31, 1986)
  • K850967 — STERILE CORMED MEDIPORT (May 17, 1985)
  • K850674 — CORMED II AMBULATORY INFUSION PUMP (April 9, 1985)
  • K843083 — CORMED HUBER POINT NEEDLE (September 5, 1984)
  • K833915 — VASCULAR ACCESS CATH. REPAIR KIT (March 30, 1984)
  • K823553 — CORCATH H & B VASCULAR ACCESS CATHETER (January 5, 1983)

Other clearances for product code LJT

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  • 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)