Penumbra System Penumbra JET 7X

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 Jet 7x.

Pre-market Notification Details

Device IDK191946
510k NumberK191946
Device Name:Penumbra System Penumbra JET 7X
ClassificationCatheter, Thrombus Retriever
Applicant Penumbra, Inc. One Penumbra Place Alameda,  CA  94502
ContactMicaela Victoria
CorrespondentMicaela Victoria
Penumbra, Inc. One Penumbra Place Alameda,  CA  94502
Product CodeNRY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelNeurology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-22
Decision Date2020-02-27

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