510(k) K101824

AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER by Amsino International, Inc. — Product Code EZL

K101824 is an FDA 510(k) premarket notification submitted by Amsino International, Inc. for the device "AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER". The FDA issued a decision of Substantially Equivalent on September 13, 2010. 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.