Home / 510(k) Clearances / K940870

510(k) K940870

UMBILI-CATH by Gesco Intl., Inc. — Product Code FOS

K940870 is an FDA 510(k) premarket notification submitted by Gesco Intl., Inc. for the device "UMBILI-CATH". The FDA issued a decision of Substantially Equivalent on August 2, 1994. The device falls under product code FOS (Catheter, Umbilical Artery), a Class II device regulated under 21 CFR 880.5200. Gesco Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1994
Date Received
February 25, 1994
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 Gesco Intl., Inc.

  • K954422 — PER-Q-CATH MID-LINE (December 15, 1995)
  • K940953 — UMBILI-CATH-S (August 2, 1994)
  • K940952 — UMBILI-CATH-S-DL (July 29, 1994)
  • K941672 — URI-CATH CATHETER (May 16, 1994)
  • K941232 — THORA-CATH (May 11, 1994)
  • K940871 — UMBILI-CATH-P (April 29, 1994)
  • K931989 — VENTRI-CATH (July 21, 1993)
  • K926063 — PER-Q-CATH DRESSING CHANGE TRAY (June 7, 1993)
  • K923591 — PALA-NATE (March 16, 1993)
  • K915167 — GESCO PER-Q-CATH CATHETER INTRODUCER (January 27, 1992)

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)
  • K091214 — FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER (September 25, 2009)
  • K091213 — FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN (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)
  • K963972 — NEO-CARE DUAL LUMEN UMBILICAL CATHETER (December 24, 1996)
  • K954300 — ARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRA (December 13, 1995)

FDA data resources