Indigo Aspiration System – Lightning Aspiration Tubing

Peripheral Mechanical Thrombectomy With Aspiration

Penumbra, Inc.

The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Indigo Aspiration System – Lightning Aspiration Tubing.

Pre-market Notification Details

Device IDK193244
510k NumberK193244
Device Name:Indigo Aspiration System – Lightning Aspiration Tubing
ClassificationPeripheral Mechanical Thrombectomy With Aspiration
Applicant Penumbra, Inc. One Penumbra Place Alameda,  CA  94502
ContactMicaela Victoria
CorrespondentMicaela Victoria
Penumbra, Inc. One Penumbra Place Alameda,  CA  94502
Product CodeQEW  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-25
Decision Date2020-03-13

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