510(k) K103086

DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC by Dynarex Corporation — Product Code EZD

K103086 is an FDA 510(k) premarket notification submitted by Dynarex Corporation for the device "DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC". The FDA issued a decision of Substantially Equivalent on June 7, 2011. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Dynarex Corporation has at least 7 other 510(k) clearances on record.