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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 K233668
Device Name 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.
Pekeris St. 3
Rehovot,  IL 7670203
Applicant Contact Yoel Zabar
Correspondent
AngioDynamics, Inc.
603 Queensbury Ave.
Queensburgy,  NY  12804
Correspondent Contact James Welsh
Regulation Number870.4875
Classification Product Code
MCW  
Date Received11/15/2023
Decision Date 12/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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