Benchmark Intracranial Access System

Catheter, Percutaneous, Neurovasculature

Penumbra, Inc.

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

Pre-market Notification Details

Device IDK212838
510k NumberK212838
Device Name:Benchmark Intracranial Access System
ClassificationCatheter, Percutaneous, Neurovasculature
Applicant Penumbra, Inc. One Penumbra Place Alameda,  CA  94502
ContactBuu Buu Ly
CorrespondentBuu Buu Ly
Penumbra, Inc. One Penumbra Place Alameda,  CA  94502
Product CodeQJP  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-07
Decision Date2022-05-27

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