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510(k) K971140

VITAL-PORT INFUSION PAL by Med Institute, Inc. — Product Code LJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1997
Date Received
March 28, 1997
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)
  • K982507 — MINI POLYURETHANE CATHETER (September 16, 1998)
  • K981061 — INTRAVASCULAR RETRIEVAL DEVICE (May 26, 1998)
  • K964001 — SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM (April 17, 1998)
  • 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)

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  • K181446 — Bard Power-Injectable Implantable Ports (PowerPorts®) (July 8, 2019)
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  • K153228 — NMI Port, NMI Port II (December 4, 2015)