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510(k) K982507

MINI POLYURETHANE CATHETER by Med Institute, Inc. — Product Code LJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1998
Date Received
July 20, 1998
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 Med Institute, Inc.

  • K990034 — WILSON-COOK COLONIC Z-STENT (April 17, 2000)
  • K981061 — INTRAVASCULAR RETRIEVAL DEVICE (May 26, 1998)
  • K964001 — SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM (April 17, 1998)
  • K971140 — VITAL-PORT INFUSION PAL (November 17, 1997)
  • K970442 — TARGET VITAL-PORT VASCULAR ACCESS SYSTEM (April 30, 1997)
  • K945586 — FLEXIBLE DILATING SHEATH (April 4, 1997)
  • K960698 — NON-CORING NEEDLE (April 15, 1996)
  • K941228 — ENDOLUMINAL ACCESS TUBE (September 27, 1995)
  • K951077 — VITAL-PORT PETIET POLYSULFONE VASCULAR ACCESS SYSTEM (July 31, 1995)
  • K951076 — VITAL-PORT PETITE DUAL VASCULAR ACCESS SYSTEM (June 13, 1995)

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)