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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