510(k) K130725

MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR. by Covidien Lp, Formerly Registered AS Kendall — Product Code FOS

K130725 is an FDA 510(k) premarket notification submitted by Covidien Lp, Formerly Registered AS Kendall for the device "MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.". The FDA issued a decision of Substantially Equivalent on April 17, 2013. The device falls under product code FOS (Catheter, Umbilical Artery), a Class II device regulated under 21 CFR 880.5200. Covidien Lp, Formerly Registered AS Kendall has at least 2 other 510(k) clearances on record.