NEURON MAX SYSTEM

Catheter, Percutaneous

PENUMBRA, INC.

The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Neuron Max System.

Pre-market Notification Details

Device IDK111380
510k NumberK111380
Device Name:NEURON MAX SYSTEM
ClassificationCatheter, Percutaneous
Applicant PENUMBRA, INC. 1351 HARBOR BAY PARKWAY Alameda,  CA  94502
ContactMichaela Mahl
CorrespondentMichaela Mahl
PENUMBRA, INC. 1351 HARBOR BAY PARKWAY Alameda,  CA  94502
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-16
Decision Date2011-07-19
Summary:summary

NIH GUDID Devices

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