Merit Siege Vascular Plug

Device, Vascular, For Promoting Embolization

Merit Medical System, Inc.

The following data is part of a premarket notification filed by Merit Medical System, Inc. with the FDA for Merit Siege Vascular Plug.

Pre-market Notification Details

Device IDK212817
510k NumberK212817
Device Name:Merit Siege Vascular Plug
ClassificationDevice, Vascular, For Promoting Embolization
Applicant Merit Medical System, Inc. 1600 West Merit Parkway South Jordan,  UT  84095
ContactMark Mullaney
CorrespondentSiobhan King
Merit Medical System, Inc. Parkmore Business Park West Galway,  IE
Product CodeKRD  
CFR Regulation Number870.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-03
Decision Date2021-12-15

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