510(k) K241553 ยท MCW Catheter, Peripheral, Atherectomy
Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating
| Applicant | Eximo Medical, Ltd., Rehovot, IL |
| Decision | Substantially Equivalent, Jun 27, 2024 |
| Received | May 31, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K241553
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 27, 2024 | Angiodynamics, Inc. AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100 Open, Classified |
MCW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.