510(k) K202049

Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter by Applied Medical Resources Corporation — Product Code DXE

K202049 is an FDA 510(k) premarket notification submitted by Applied Medical Resources Corporation for the device "Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter". The FDA issued a decision of Substantially Equivalent on September 7, 2021. The device falls under product code DXE (Catheter, Embolectomy), a Class II device regulated under 21 CFR 870.5150. Applied Medical Resources Corporation has at least 10 other 510(k) clearances on record.