510(k) K181814

AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water by Amsino International, Inc. — Product Code EZL

K181814 is an FDA 510(k) premarket notification submitted by Amsino International, Inc. for the device "AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water". The FDA issued a decision of Substantially Equivalent on September 4, 2018. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Amsino International, Inc. has at least 10 other 510(k) clearances on record.