Elation Pulmonary Balloon Dilation

Bronchoscope Accessory

MERIT MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Elation Pulmonary Balloon Dilation.

Pre-market Notification Details

Device IDK161392
510k NumberK161392
Device Name:Elation Pulmonary Balloon Dilation
ClassificationBronchoscope Accessory
Applicant MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PARKWAY South Jordan,  UT  84095
ContactDavid Thomas
CorrespondentDavid Thomas
MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PARKWAY South Jordan,  UT  84095
Product CodeKTI  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-05-19
Decision Date2016-09-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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10884450398927 K161392 000
10884450197957 K161392 000

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