510(k) K911181

INTIMAX(TM) IRRIGATION CATHETER by Applied Vascular Devices, Inc. — Product Code GCA

K911181 is an FDA 510(k) premarket notification submitted by Applied Vascular Devices, Inc. for the device "INTIMAX(TM) IRRIGATION CATHETER". The FDA issued a decision of Substantially Equivalent on April 18, 1991. The device falls under product code GCA (Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection), a Class II device regulated under 21 CFR 876.5010. Applied Vascular Devices, Inc. has at least 10 other 510(k) clearances on record.