BENCHMARK BMX81 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 Bmx81 Access System.

Pre-market Notification Details

Device IDK221822
510k NumberK221822
Device Name:BENCHMARK BMX81 Access System
ClassificationCatheter, Percutaneous, Neurovasculature
Applicant Penumbra, Inc One Penumbra Place Alameda,  CA  95132
ContactSindokht (Sisi) Soltanzadeh
CorrespondentSindokht Soltanzadeh
Penumbra, Inc One Penumbra Place Alameda,  CA  95132
Product CodeQJP  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-23
Decision Date2022-11-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00815948024670 K221822 000
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00815948024526 K221822 000
00815948024533 K221822 000
00815948024540 K221822 000
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00815948024632 K221822 000
00815948024649 K221822 000
00815948024656 K221822 000
00815948024663 K221822 000
00815948024502 K221822 000

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