510(k) K233668 ยท MCW Catheter, Peripheral, Atherectomy
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)
| Applicant | Eximo Medical, Ltd., Rehovot, IL |
| Decision | Substantially Equivalent, Dec 15, 2023 |
| Received | Nov 15, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K233668
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.