Cleared Special

Indigo Aspiration System - Lightning Aspiration Tubing

K210323 · Penumbra, Inc. · Cardiovascular

Feb 2021

Decision

22d

Days

Class 2

Risk

About This 510(k) Submission

K210323 is an FDA 510(k) clearance for the Indigo Aspiration System - Lightning Aspiration Tubing, 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 26, 2021, 22 days after receiving the submission on February 4, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K210323 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 04, 2021
Decision Date	February 26, 2021
Days to Decision	22 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.