PENUMBRA CATHERER 025

Catheter, Percutaneous

PENUMBRA, INC.

The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra Catherer 025.

Pre-market Notification Details

Device IDK100826
510k NumberK100826
Device Name:PENUMBRA CATHERER 025
ClassificationCatheter, Percutaneous
Applicant PENUMBRA, INC. 1351 HARBOR BAY PKWY. Alameda,  CA  94502
ContactSeth A Schulman
CorrespondentSeth A Schulman
PENUMBRA, INC. 1351 HARBOR BAY PKWY. Alameda,  CA  94502
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-03-24
Decision Date2010-07-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00814548012605 K100826 000
00814548010342 K100826 000

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