Penumbra LP Coil System

Device, Neurovascular Embolization

Penumbra, Inc.

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

Pre-market Notification Details

Device IDK192955
501k NumberK192955
Device Name:Penumbra LP Coil System
ClassificationDevice, Neurovascular Embolization
Applicant Penumbra, Inc. One Penumbra Place Alameda,  CA  94502
ContactAnush Puvvada
CorrespondentAnush Puvvada
Penumbra, Inc. One Penumbra Place Alameda,  CA  94502
Product CodeHCG  
CFR Regulation Number882.5950 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
501k Review PanelNeurology
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-21
Decision Date2019-11-20

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