Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12

Catheter, Embolectomy

Penumbra, Inc

The following data is part of a premarket notification filed by Penumbra, Inc with the FDA for Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12.

Pre-market Notification Details

Device IDK192981
510k NumberK192981
Device Name:Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12
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 Received2019-10-24
Decision Date2020-05-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00815948022553 K192981 000

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