Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000)

About This 510(k) Submission

K233668 is an FDA 510(k) clearance for the Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000), a Catheter, Peripheral, Atherectomy (Class II — Special Controls, product code MCW), submitted by Eximo Medical, Ltd. (Rehovot, IL). The FDA issued a Cleared decision on December 15, 2023, 30 days after receiving the submission on November 15, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.