HEADWAY 27 MICROCATHETER

Catheter, Percutaneous

MICRO VENTION, INC.

The following data is part of a premarket notification filed by Micro Vention, Inc. with the FDA for Headway 27 Microcatheter.

Pre-market Notification Details

Device IDK110813
510k NumberK110813
Device Name:HEADWAY 27 MICROCATHETER
ClassificationCatheter, Percutaneous
Applicant MICRO VENTION, INC. 1311 VALENCIA AVENUE Tustin,  CA  92780
ContactNaomi Gong
CorrespondentNaomi Gong
MICRO VENTION, INC. 1311 VALENCIA AVENUE Tustin,  CA  92780
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-24
Decision Date2011-08-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00811425020449 K110813 000
00810170016165 K110813 000

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