FDA 510(k) Applications Submitted by Eximo Medical, Ltd.

FDA 510(k) Number Submission Date Device Name Applicant
K241553 05/31/2024 Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating Eximo Medical, Ltd.
K233668 11/15/2023 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 Eximo Medical, Ltd.


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