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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 K181642
Device Name B-Laser Atherectomy System
Applicant
Eximo Medical, Ltd.
3 Pekeris St.
Rehovot,  IL 7670203
Applicant Contact Yossi Muncher
Correspondent
Hogan Lovells US LLP
1735 Market St.
Floor 23
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number870.4875
Classification Product Code
MCW  
Date Received06/21/2018
Decision Date 10/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT02556255
NCT03157531
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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