510(k) K140085

UNIVERSA PERCULTANEOUS DRAINAGE CATHETER by Cook Incorporated — Product Code FEW

K140085 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "UNIVERSA PERCULTANEOUS DRAINAGE CATHETER". The FDA issued a decision of Substantially Equivalent on November 18, 2014. The device falls under product code FEW (Catheter, Malecot), a Class II device regulated under 21 CFR 876.5090. Cook Incorporated has at least 10 other 510(k) clearances on record.