Catheter, Peripheral, Atherectomy
Eximo Medical Ltd's record for this product code
MDR events114All time
Recalls0All time
510(k) clearances7All time
Recent MDR events
114 adverse event reports on file
- AURYON ATHERECTOMY CATHETERJul 15, 2026Injury1319211-2026-10030
- AURYON ATHERECTOMY CATHETERJul 2, 2026Injury1319211-2026-10028
- AURYON¿ ATHERECTOMY SYSTEMJul 2, 2026Injury1319211-2026-10026
- AURYON ATHERECTOMY CATHETERJul 2, 2026Injury1319211-2026-10027
- AURYON ATHERECTOMY CATHETERJul 2, 2026Injury1319211-2026-10029
- AURYON¿ ATHERECTOMY SYSTEMJul 2, 2026Injury1319211-2026-10025
- AURYON ATHERECTOMY CATHETERJun 23, 2026Malfunction1319211-2026-10023
- AURYON ATHERECTOMY CATHETERJun 23, 2026Malfunction1319211-2026-10022
- AURYON ATHERECTOMY CATHETERJun 23, 2026Malfunction1319211-2026-10024
- CATHETER EXIMO ATHERECTOMYJun 10, 2026Injury1319211-2026-10120
Recalls
0 recall events for this product code
No recalls on file for Eximo Medical Ltd under this product code.
510(k) clearances
7 clearances for this product code
- K241553Jun 27, 2024
Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating
- K233668Dec 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-4011-0000)
- K230709Jun 9, 2023
Auryon Atherectomy System
- K220116Sep 26, 2022
Auryon Atherectomy Catheters
- K221077Jun 9, 2022
Auryon Atherectomy System
- K202835Dec 2, 2020
Auryon Atherectomy System
- K181642Oct 5, 2018
B-Laser Atherectomy System