Indigo Aspiration System - Aspiration Catheter 7 And Separator 7

Catheter, Embolectomy

Penumbra, Inc.

The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Indigo Aspiration System - Aspiration Catheter 7 And Separator 7.

Pre-market Notification Details

Device IDK193595
510k NumberK193595
Device Name:Indigo Aspiration System - Aspiration Catheter 7 And Separator 7
ClassificationCatheter, Embolectomy
Applicant Penumbra, Inc. One Penumbra Place Alameda,  CA  94502
ContactTeri Nguyen
CorrespondentTeri Nguyen
Penumbra, Inc. One Penumbra Place Alameda,  CA  94502
Product CodeDXE  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-23
Decision Date2020-08-19

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