510(k) K132500

CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED by Cure Medical, LLC — Product Code EZD

K132500 is an FDA 510(k) premarket notification submitted by Cure Medical, LLC for the device "CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED". The FDA issued a decision of Substantially Equivalent on December 23, 2013. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Cure Medical, LLC has at least 3 other 510(k) clearances on record.