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

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00815948023086 K201271 000
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00815948022706 K201271 000
00815948022713 K201271 000
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00815948023048 K201271 000
00815948023055 K201271 000
00815948023062 K201271 000
00815948023079 K201271 000
00815948022607 K201271 000

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