Extroducer Infusion Catheter System

Catheter, Continuous Flush

Smartwise Sweden AB

The following data is part of a premarket notification filed by Smartwise Sweden Ab with the FDA for Extroducer Infusion Catheter System.

Pre-market Notification Details

Device IDK213442
510k NumberK213442
Device Name:Extroducer Infusion Catheter System
ClassificationCatheter, Continuous Flush
Applicant Smartwise Sweden AB Alfred Nobels Allé 150 Tullinge,  SE SE-146 48
ContactMaria Nordlinder
CorrespondentMaria Nordlinder
Smartwise Sweden AB Alfred Nobels Allé 150 Tullinge,  SE SE-146 48
Product CodeKRA  
CFR Regulation Number870.1210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-10-25
Decision Date2022-06-10

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