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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 K240864
Device Name PacePro Wire
Applicant
Opsens, Inc.
750 Blvd. Du Parc Technologique
Quebec,  CA G1P 4S3
Applicant Contact Marc Chaunet
Correspondent
Opsens, Inc.
750 Blvd. Du Parc Technologique
Quebec,  CA G1P 4S3
Correspondent Contact Marc Chaunet
Regulation Number870.1330
Classification Product Code
DQX  
Subsequent Product Code
LDF  
Date Received03/28/2024
Decision Date 05/24/2024
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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