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510(k) K963972

NEO-CARE DUAL LUMEN UMBILICAL CATHETER by Klein-Baker Medical, Inc. — Product Code FOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 1996
Date Received
October 3, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Umbilical Artery
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Other clearances by Klein-Baker Medical, Inc.

  • K972731 — NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET (September 29, 1997)
  • K970997 — NEO-CARE LUMBER PUNCTURE KIT (May 22, 1997)
  • K970434 — NEO-PICC (April 1, 1997)
  • K963867 — NEO-CARE CATHETERIZATION TRAY (November 6, 1996)

Other clearances for product code FOS

  • K201697 — Umbilical Vessels Catheter (May 6, 2021)
  • K130725 — MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR. (April 17, 2013)
  • K120304 — FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER (March 1, 2012)
  • K091213 — FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN (September 25, 2009)
  • K091214 — FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER (September 25, 2009)
  • K081515 — NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 (July 21, 2008)
  • K073596 — NEOMED SINGLE LUMEN UMBILICAL CATHETER (February 22, 2008)
  • K981630 — VYGON DOUBLE LUMEN UMBILICAL CATHETER (October 1, 1998)
  • K954300 — ARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRA (December 13, 1995)
  • K951738 — ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER (September 29, 1995)