510(k) K172807

Silicone Foley Catheter for single use by Changzhou Rongxin Medicine Minimal Invasion Technology — Product Code EZL

K172807 is an FDA 510(k) premarket notification submitted by Changzhou Rongxin Medicine Minimal Invasion Technology for the device "Silicone Foley Catheter for single use". The FDA issued a decision of Substantially Equivalent on Jun 4, 2018. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130.