The following data is part of a premarket notification filed by Eximo Medical Ltd. with the FDA for Auryon Atherectomy System.
| Device ID | K202835 |
| 510k Number | K202835 |
| Device Name: | Auryon Atherectomy System |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | Eximo Medical Ltd. Pekeris St 3 Rehovot, IL 7670203 |
| Contact | Yoel Zabar |
| Correspondent | James Welsh AngioDynamics 603 Queensbury Avenue Queensbury, NY 12804 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-25 |
| Decision Date | 2020-12-02 |