PG Pro Microcatheter

Catheter, Percutaneous

MicroVention, Inc., A Terumo Group Company

The following data is part of a premarket notification filed by Microvention, Inc., A Terumo Group Company with the FDA for Pg Pro Microcatheter.

Pre-market Notification Details

Device IDK192625
501k NumberK192625
Device Name:PG Pro Microcatheter
ClassificationCatheter, Percutaneous
Applicant MicroVention, Inc., A Terumo Group Company 35 Enterprise Aliso Viejo,  CA  92656
ContactGanesh Balachandar
CorrespondentGanesh Balachandar
MicroVention, Inc., A Terumo Group Company 35 Enterprise Aliso Viejo,  CA  92656
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
501k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-23
Decision Date2019-11-21

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