The following data is part of a premarket notification filed by Eximo Medical Ltd. with the FDA for Auryon Atherectomy Catheters.
| Device ID | K220116 |
| 510k Number | K220116 |
| Device Name: | Auryon Atherectomy Catheters |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | Eximo Medical Ltd. Pekeris St 3 Rehovot, IL 7670203 |
| Contact | Yoel Zabar |
| Correspondent | James Welsh AngioDynamics 603 Queensbury Ave Queensburgy, NY 12804 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-14 |
| Decision Date | 2022-09-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290017590172 | K220116 | 000 |
| 07290017590165 | K220116 | 000 |
| 07290017590158 | K220116 | 000 |
| 07290017590141 | K220116 | 000 |