Eximo Medical, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Auryon Atherectomy Catheter 1.7mm, 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), Auryon Atherectomy System
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Eximo Medical, Ltd. Cardiovascular ✕
7 devices
Cleared
Jun 27, 2024
Auryon Atherectomy Catheter 1.7mm
Cardiovascular
27d
Cleared
Dec 15, 2023
Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000),...
Cardiovascular
30d
Cleared
Jun 09, 2023
Auryon Atherectomy System
Cardiovascular
87d
Cleared
Sep 26, 2022
Auryon Atherectomy Catheters
Cardiovascular
255d
Cleared
CT
Jun 09, 2022
Auryon Atherectomy System
Cardiovascular
58d
Cleared
CT
Dec 02, 2020
Auryon Atherectomy System
Cardiovascular
68d
Cleared
CT
Oct 05, 2018
B-Laser Atherectomy System
Cardiovascular
106d