510(k) K183323

UPJ Occlusion Balloon Catheter by Cook Incorporated — Product Code EYB

K183323 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "UPJ Occlusion Balloon Catheter". The FDA issued a decision of Substantially Equivalent (kit) on August 5, 2019. The device falls under product code EYB (Catheter, Ureteral, Gastro-Urology), a Class II device regulated under 21 CFR 876.5130. Cook Incorporated has at least 10 other 510(k) clearances on record.