Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter

About This 510(k) Submission

K202049 is an FDA 510(k) clearance for the Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter, a Catheter, Embolectomy (Class II — Special Controls, product code DXE), submitted by Applied Medical Resources Corporation (Rancho Santa, US). The FDA issued a Cleared decision on September 7, 2021, 410 days after receiving the submission on July 24, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.