510(k) K170362

VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS by Coloplast Corp. — Product Code FAD

K170362 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS". The FDA issued a decision of Substantially Equivalent on Nov 15, 2017. 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.