510(k) K061766

EXPRESSWAY INTERMITTENT CATHETER by Percutaneous Systems, Incorporated — Product Code EZD

K061766 is an FDA 510(k) premarket notification submitted by Percutaneous Systems, Incorporated for the device "EXPRESSWAY INTERMITTENT CATHETER". The FDA issued a decision of Substantially Equivalent on March 9, 2007. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Percutaneous Systems, Incorporated has at least 4 other 510(k) clearances on record.