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510(k) K120304

FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER by Footprint Medical, Inc. — Product Code FOS

K120304 is an FDA 510(k) premarket notification submitted by Footprint Medical, Inc. for the device "FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER". The FDA issued a decision of Substantially Equivalent on March 1, 2012. The device falls under product code FOS (Catheter, Umbilical Artery), a Class II device regulated under 21 CFR 880.5200. Footprint Medical, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2012
Date Received
February 1, 2012
Clearance Type
Special
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 Footprint Medical, Inc.

  • K130507 — FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER (June 3, 2013)
  • K102548 — FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE (November 26, 2010)
  • K093026 — FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER (February 24, 2010)
  • K093252 — FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER (December 17, 2009)
  • K091213 — FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN (September 25, 2009)
  • K091214 — FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER (September 25, 2009)
  • K091488 — FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C (September 14, 2009)
  • K090576 — FOOTPRINT URINARY DRAINAGE CATHETER (August 12, 2009)
  • K090559 — FOOTPRINT MEDICAL SILICONE FEEDING TUBE (May 4, 2009)

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)
  • 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)
  • K963972 — NEO-CARE DUAL LUMEN UMBILICAL CATHETER (December 24, 1996)
  • 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)

FDA data resources