510(k) K864669

AM CATH ESWL STENT by Inter-Med Corp. — Product Code FAD

K864669 is an FDA 510(k) premarket notification submitted by Inter-Med Corp. for the device "AM CATH ESWL STENT". The FDA issued a decision of Substantially Equivalent on January 5, 1987. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Inter-Med Corp. has at least 10 other 510(k) clearances on record.