Benchmark BMX96 Access System

Catheter, Percutaneous

Penumbra, Inc.

The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Benchmark Bmx96 Access System.

Pre-market Notification Details

Device IDK201271
510k NumberK201271
Device Name:Benchmark BMX96 Access System
ClassificationCatheter, Percutaneous
Applicant Penumbra, Inc. One Penumbra Place Alameda,  CA  94502
ContactMatthew Benenati
CorrespondentMatthew Benenati
Penumbra, Inc. One Penumbra Place Alameda,  CA  94502
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-12
Decision Date2020-06-11

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