510(k) K181445

AMSure Hydrophilic Intermittent Catheter by Amsino International, Inc. — Product Code EZD

K181445 is an FDA 510(k) premarket notification submitted by Amsino International, Inc. for the device "AMSure Hydrophilic Intermittent Catheter". The FDA issued a decision of Substantially Equivalent on October 1, 2018. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Amsino International, Inc. has at least 10 other 510(k) clearances on record.