VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)

Catheter, Percutaneous

MicroVention, Inc.

The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Via Microcatheter (size 17), Via Microcatheter (size 21), Via Microcatheter (size 27), Via Microcatheter (size 33).

Pre-market Notification Details

Device IDK192135
510k NumberK192135
Device Name:VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)
ClassificationCatheter, Percutaneous
Applicant MicroVention, Inc. 1311 Valencia Ave. Tustin,  CA  92780
ContactSapna Singh
CorrespondentSapna Singh
MicroVention, Inc. 1311 Valencia Ave. Tustin,  CA  92780
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-07
Decision Date2019-12-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842429106457 K192135 000
00842429106440 K192135 000
00842429106433 K192135 000
00842429106426 K192135 000
00842429106419 K192135 000
00842429106402 K192135 000

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