Cleared Special

Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7

K210083 · Penumbra, Inc. · Cardiovascular

Feb 2021

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K210083 is an FDA 510(k) clearance for the Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7, a Peripheral Mechanical Thrombectomy With Aspiration (Class II — Special Controls, product code QEW), submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on February 9, 2021, 28 days after receiving the submission on January 12, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K210083 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 12, 2021
Decision Date	February 09, 2021
Days to Decision	28 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	QEW — Peripheral Mechanical Thrombectomy With Aspiration
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.5150
Definition	To Mechanically Disrupt Thrombus And/or Debris Prior To Removal From The Peripheral Vasculature Through Aspiration.