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FOS — Catheter, Umbilical Artery Class II

FDA Device Classification

Classification Details

Product Code
FOS
Device Class
Class II
Regulation Number
880.5200
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K201697haolang medical usa corporationUmbilical Vessels CatheterMay 6, 2021
K130725covidien lp, formerly registered as kendallMODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.April 17, 2013
K120304footprint medicalFOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETERMarch 1, 2012
K091213footprint medicalFOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMENSeptember 25, 2009
K091214footprint medicalFOOTPRINT MEDICAL SILICONE UMBILICAL CATHETERSeptember 25, 2009
K081515neomedNEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0July 21, 2008
K073596neomedNEOMED SINGLE LUMEN UMBILICAL CATHETERFebruary 22, 2008
K981630schiff andVYGON DOUBLE LUMEN UMBILICAL CATHETEROctober 1, 1998
K963972klein-baker medicalNEO-CARE DUAL LUMEN UMBILICAL CATHETERDecember 24, 1996
K954300sherwood medicalARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRADecember 13, 1995
K951738sherwood medicalARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETERSeptember 29, 1995
K951737sherwood medicalARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER INSERTION TRAYSeptember 28, 1995
K942353tri-state hospital supplyCENTURION UMBILICAL CATHETERAugust 15, 1995
K941429becton dickinson vascular accessIV CATHETER AND OBTURATORJanuary 4, 1995
K942827sentry medical productsSENTRY INSERTION TRAYNovember 2, 1994
K941814sherwood medicalARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETERSeptember 30, 1994
K942564sherwood medicalARGYLE NEO-SERTAugust 25, 1994
K940953gesco intlUMBILI-CATH-SAugust 2, 1994
K940870gesco intlUMBILI-CATHAugust 2, 1994
K940952gesco intlUMBILI-CATH-S-DLJuly 29, 1994