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510(k) K951076

VITAL-PORT PETITE DUAL VASCULAR ACCESS SYSTEM by Med Institute, Inc. — Product Code LJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1995
Date Received
March 9, 1995
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)
  • 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)

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  • K153359 — BardPort®, SlimPort®, and X-Port® Implanted Ports (May 20, 2016)
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  • K153228 — NMI Port, NMI Port II (December 4, 2015)