510(k) K201007

In-Ka Ureteral Balloon Dilatation Catheter by Coloplast Corp. — Product Code EZN

K201007 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "In-Ka Ureteral Balloon Dilatation Catheter". The FDA issued a decision of Substantially Equivalent (kit) on June 11, 2020. The device falls under product code EZN (Dilator, Catheter, Ureteral), a Class II device regulated under 21 CFR 876.5470. Coloplast Corp. has at least 10 other 510(k) clearances on record.