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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter For Crossing Total Occlusions
510(k) Number K210839
Device Name SoundBite Crossing System - Peripheral (14P)
Applicant
Soundbite Medical Solutions, Inc.
2300 Boulevard Alfred-Nobel
Montreal,  CA H4S 2A4
Applicant Contact Dominique Abecassis
Correspondent
Soundbite Medical Solutions, Inc.
2300 Boulevard Alfred-Nobel
Montreal,  CA H4S 2A4
Correspondent Contact Dominique Abecassis
Regulation Number870.1250
Classification Product Code
PDU  
Date Received03/22/2021
Decision Date 04/20/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Clinical Trials NCT03266835
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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