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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 K213854
Device Name SavvyWire
Applicant
Opsens, Inc.
750 Blvd. Du Parc Technologique
Quebec,  CA G1P 4S3
Applicant Contact Marc Chaunet
Correspondent
Ultra Life Science Solutions, Inc.
2811 Milton Ave. #409
Janesville,  WI  53545
Correspondent Contact Christina Henza
Regulation Number870.1330
Classification Product Code
DQX  
Subsequent Product Codes
DXO   LDF  
Date Received12/10/2021
Decision Date 09/14/2022
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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