510(k) K172588

Balloon Catheter and Balloon Ureteral Dilator Set by Cook Incorporated — Product Code EZN

K172588 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Balloon Catheter and Balloon Ureteral Dilator Set". The FDA issued a decision of Substantially Equivalent (kit) on April 19, 2018. The device falls under product code EZN (Dilator, Catheter, Ureteral), a Class II device regulated under 21 CFR 876.5470. Cook Incorporated has at least 10 other 510(k) clearances on record.