510(k) K180057

VORTEK URETERAL DOUBLE LOOP STENT by Coloplast Corp. — Product Code FAD

K180057 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "VORTEK URETERAL DOUBLE LOOP STENT". The FDA issued a decision of Substantially Equivalent on Mar 9, 2018. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Coloplast Corp. has 139 other 510(k) clearances on record.