510(k) K024010

DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER by The Kendall Company Div. of Tyco Healthcare Group — Product Code EZL

K024010 is an FDA 510(k) premarket notification submitted by The Kendall Company Div. of Tyco Healthcare Group for the device "DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER". The FDA issued a decision of Substantially Equivalent on June 11, 2003. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. The Kendall Company Div. of Tyco Healthcare Group has at least 3 other 510(k) clearances on record.