Penumbra Embolectomy Aspiration System [INDIGO System]

Catheter, Embolectomy

PENUMBRA, INC.

The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra Embolectomy Aspiration System [indigo System].

Pre-market Notification Details

Device IDK142870
510k NumberK142870
Device Name:Penumbra Embolectomy Aspiration System [INDIGO System]
ClassificationCatheter, Embolectomy
Applicant PENUMBRA, INC. 1351 HARBOR BAY PKWY. Alameda,  CA  94502
ContactMichael Mahl
CorrespondentMichael Mahl
PENUMBRA, INC. 1351 HARBOR BAY PKWY. Alameda,  CA  94502
Product CodeDXE  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-01
Decision Date2015-05-26
Summary:summary

NIH GUDID Devices

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