K260244
Substantially EquivalentAuryon Atherectomy System
The Auryon Atherectomy System is a laser-based peripheral atherectomy device for removing plaque from peripheral arteries — primarily in the legs and below the knee. Product code MCW covers catheter-based atherectomy devices. Auryon is AngioDynamics' platform (originally from Eximo Medical, which AngioDynamics acquired); continuing filings from Eximo Medical suggest ongoing regulatory maintenance post-acquisition.
Cardiovascular panel, Traditional 510(k). Laser atherectomy sits in a specialized niche within MCW alongside directional (Philips), orbital (Abbott), and rotational (Boston Scientific) platforms.
Eximo Medical files from Rehovot, Israel, where the original development occurred. Roughly two-and-a-half-month review clock, unusually short for Cardiovascular panel on a device with this complexity.
- Applicant
- Eximo Medical
- Product code
- MCW
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rehovot, IL
Adverse events under product code MCW
product code MCW- Death
- 38
- Injury
- 1,386
- Malfunction
- 2,676
- Other
- 2
- Total
- 4,102
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.