510(k) K260244

Device
Auryon Atherectomy System
Applicant
Eximo Medical
510(k) number
K260244
Product code
MCW
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-10
Date received
2026-01-27
Regulation
870.4875
Classification name
Catheter, Peripheral, Atherectomy
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Kasey Newcomb
Address
Pekeris St. 3 Rehovot IL 7670203 7670203

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
07290017590110Auryon Laser System 100-120 VacEXIMO MEDICAL LTD2020-05-20

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