510(k) K190612

EQUINOX Balloon Dilatation Catheter by Dornier Medtech America, Inc. — Product Code EZN

K190612 is an FDA 510(k) premarket notification submitted by Dornier Medtech America, Inc. for the device "EQUINOX Balloon Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on December 6, 2019. The device falls under product code EZN (Dilator, Catheter, Ureteral), a Class II device regulated under 21 CFR 876.5470. Dornier Medtech America, Inc. has at least 10 other 510(k) clearances on record.