Squirt Fluid Delivery System

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 Squirt Fluid Delivery System.

Pre-market Notification Details

Device IDK162777
510k NumberK162777
Device Name:Squirt Fluid Delivery System
ClassificationCatheter, Continuous Flush
Applicant Merit Medical Systems, Inc. 1600 W Merit Parkway South Jordan,  UT  84095
ContactAngela Brady
CorrespondentAngela Brady
Merit Medical Systems, Inc. 1600 W Merit Parkway South Jordan,  UT  84095
Product CodeKRA  
CFR Regulation Number870.1210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-10-03
Decision Date2016-10-31
Summary:summary

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