510(k) K940370

AMERICAN CATHETER E.R.C.P. CANNULA by Intl. Medical, Inc. — Product Code FGE

K940370 is an FDA 510(k) premarket notification submitted by Intl. Medical, Inc. for the device "AMERICAN CATHETER E.R.C.P. CANNULA". The FDA issued a decision of Substantially Equivalent on August 17, 1994. The device falls under product code FGE (Stents, Drains And Dilators For The Biliary Ducts), a Class II device regulated under 21 CFR 876.5010. Intl. Medical, Inc. has at least 10 other 510(k) clearances on record.