Penumbra System 3D Revascularization Device

Catheter, Thrombus Retriever

Penumbra, Inc.

The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra System 3d Revascularization Device.

Pre-market Notification Details

Device IDK190464
510k NumberK190464
Device Name:Penumbra System 3D Revascularization Device
ClassificationCatheter, Thrombus Retriever
Applicant Penumbra, Inc. One Penumbra Place Alameda,  CA  94502
ContactDenise Aycox
CorrespondentDenise Aycox
Penumbra, Inc. One Penumbra Place Alameda,  CA  94502
Product CodeNRY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-26
Decision Date2019-04-26

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