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FDA 510(k) Applications Submitted by Teri Nguyen
FDA 510(k) Number
Submission Date
Device Name
Applicant
K210083
01/12/2021
Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7
Penumbra, Inc.
K211476
05/12/2021
ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing
Imperative Care Inc.
K192833
10/02/2019
Indigo Aspiration System
Penumbra, Inc.
K192981
10/24/2019
Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12
Penumbra, Inc
K193595
12/23/2019
Indigo Aspiration System - Aspiration Catheter 7 and Separator 7
Penumbra, Inc.
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