SOFIA Plus Aspiration Catheter

Catheter, Thrombus Retriever

MicroVention, Inc.

The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Sofia Plus Aspiration Catheter.

Pre-market Notification Details

Device IDK173200
510k NumberK173200
Device Name:SOFIA Plus Aspiration Catheter
ClassificationCatheter, Thrombus Retriever
Applicant MicroVention, Inc. 1311 Valencia Avenue Tustin,  CA  92780
ContactNaomi Gong
CorrespondentNaomi Gong
MicroVention, Inc. 1311 Valencia Avenue Tustin,  CA  92780
Product CodeNRY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-10-02
Decision Date2018-06-11
Summary:summary

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