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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wire, guide, catheter
510(k) Number K191907
Device Name OptoWire III
Applicant
Opsens Inc.
750 Boulevard du Parc Technologique
Québec,  CA G1P 4S3
Applicant Contact Marc Chaunet
Correspondent
Ultra LifeScience Solutions Inc.
872 S. Milwaukee Ave #286
Libertyville,  IL  60048
Correspondent Contact Chris Henza
Regulation Number870.1330
Classification Product Code
DQX  
Subsequent Product Code
DXO  
Date Received07/16/2019
Decision Date 01/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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