510(k) K181616

PSM 3-Way Silicone Foley Catheter by Pathway, LLC — Product Code EZL

K181616 is an FDA 510(k) premarket notification submitted by Pathway, LLC for the device "PSM 3-Way Silicone Foley Catheter". The FDA issued a decision of Substantially Equivalent on September 21, 2018. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Pathway, LLC has at least 2 other 510(k) clearances on record.