510(k) K091306

AMSURE PVC INTERMITTENT CATHETER by Amsino International, Inc. — Product Code EZD

K091306 is an FDA 510(k) premarket notification submitted by Amsino International, Inc. for the device "AMSURE PVC INTERMITTENT CATHETER". The FDA issued a decision of Substantially Equivalent on August 21, 2009. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Amsino International, Inc. has at least 10 other 510(k) clearances on record.