Penumbra System, Penumbra Pump MAX

Catheter, Thrombus Retriever

PENUMBRA, INC.

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

Pre-market Notification Details

Device IDK160449
510k NumberK160449
Device Name:Penumbra System, Penumbra Pump MAX
ClassificationCatheter, Thrombus Retriever
Applicant PENUMBRA, INC. ONE PENUMBRA PLACE Alameda,  CA  94502
ContactRichard Kimura
CorrespondentRichard Kimura
PENUMBRA, INC. ONE PENUMBRA PLACE Alameda,  CA  94502
Product CodeNRY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-18
Decision Date2016-05-25
Summary:summary

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