ClariVein IC

Catheter, Continuous Flush

Merit Medical Systems, Inc.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Clarivein Ic.

Pre-market Notification Details

Device IDK201907
510k NumberK201907
Device Name:ClariVein IC
ClassificationCatheter, Continuous Flush
Applicant Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan,  UT  84095
ContactMichaela Rivkowich
CorrespondentMichaela Rivkowich
Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan,  UT  84095
Product CodeKRA  
CFR Regulation Number870.1210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-09
Decision Date2020-08-06

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