Cleared Traditional

Indigo Aspiration System - Lightning Flash

K222358 · Penumbra, Inc. · Cardiovascular

Dec 2022

Decision

138d

Days

Class 2

Risk

About This 510(k) Submission

K222358 is an FDA 510(k) clearance for the Indigo Aspiration System - Lightning Flash, 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 December 20, 2022, 138 days after receiving the submission on August 4, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K222358 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 04, 2022
Decision Date	December 20, 2022
Days to Decision	138 days
Submission Type	Traditional
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.