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510(k) K911607

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

K911607 is an FDA 510(k) premarket notification submitted by Gesco Intl., Inc. for the device "GESCO UMBILI-CATH". The FDA issued a decision of Substantially Equivalent on June 11, 1991. 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
June 11, 1991
Date Received
April 10, 1991
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)
  • K940870 — UMBILI-CATH (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)

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