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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peripheral, Atherectomy
510(k) Number K220116
Device Name Auryon Atherectomy Catheters
Applicant
Eximo Medical, Ltd.
Pekeris St. 3
Rehovot,  IL 7670203
Applicant Contact Yoel Zabar
Correspondent
Angiodynamics
603 Queensbury Ave.
Queensburgy,  NY  12804
Correspondent Contact James Welsh
Regulation Number870.4875
Classification Product Code
MCW  
Date Received01/14/2022
Decision Date 09/26/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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