Advocate PTA Catheter

Catheter, Angioplasty, Peripheral, Transluminal

Merit Medical Systems Inc.

The following data is part of a premarket notification filed by Merit Medical Systems Inc. with the FDA for Advocate Pta Catheter.

Pre-market Notification Details

Device IDK192907
510k NumberK192907
Device Name:Advocate PTA Catheter
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant Merit Medical Systems Inc. Parkmore Business Park West Galway,  IE N-a
ContactMark Mullaney
CorrespondentMichael O'sullivan
Merit Medical Systems Inc. Parkmore Business Park West Galway,  IE N-a
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-15
Decision Date2019-11-26
Summary:summary

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