510(k) K191187

Dornier MINNOW Ureteral Catheter by Dornier Medtech America, Inc. — Product Code EYB

K191187 is an FDA 510(k) premarket notification submitted by Dornier Medtech America, Inc. for the device "Dornier MINNOW Ureteral Catheter". The FDA issued a decision of Substantially Equivalent on September 18, 2019. The device falls under product code EYB (Catheter, Ureteral, Gastro-Urology), a Class II device regulated under 21 CFR 876.5130. Dornier Medtech America, Inc. has at least 10 other 510(k) clearances on record.