Artemis Neuro Evacuation Device

Endoscope, Neurological

Penumbra, Inc.

The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Artemis Neuro Evacuation Device.

Pre-market Notification Details

Device IDK171332
510k NumberK171332
Device Name:Artemis Neuro Evacuation Device
ClassificationEndoscope, Neurological
Applicant Penumbra, Inc. One Penumbra Place Alameda,  CA  94502
ContactMary Rose
CorrespondentMary Rose
Penumbra, Inc. One Penumbra Place Alameda,  CA  94502
Product CodeGWG  
CFR Regulation Number882.1480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-05-08
Decision Date2017-08-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00814548017877 K171332 000
00814548017860 K171332 000
00814548017846 K171332 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.