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Eximo Medical, Ltd.

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories1
Latest FDA decision2024-06-27
TypeNumberDevice NameCodeDateActions
510(k) K241553 Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingMCW2024-06-27 View
510(k) K233668 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)MCW2023-12-15 View
510(k) K230709 Auryon Atherectomy SystemMCW2023-06-09 View
510(k) K220116 Auryon Atherectomy CathetersMCW2022-09-26 View
510(k) K221077 Auryon Atherectomy SystemMCW2022-06-09 View
510(k) K202835 Auryon Atherectomy SystemMCW2020-12-02 View
510(k) K181642 B-Laser Atherectomy SystemMCW2018-10-05 View
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