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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K213442
Device Name Extroducer Infusion Catheter System
Applicant
SmartWise Sweden AB
Alfred Nobels Allé 150
Tullinge,  SE SE-146 48
Applicant Contact Maria Nordlinder
Correspondent
SmartWise Sweden AB
Alfred Nobels Allé 150
Tullinge,  SE SE-146 48
Correspondent Contact Maria Nordlinder
Regulation Number870.1210
Classification Product Code
KRA  
Date Received10/25/2021
Decision Date 06/10/2022
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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