Cleared Special

Indigo? Lightning Flash Aspiration System ? Select +? Catheter

K241399 · Penumbra, Inc. · Cardiovascular

Jun 2024

Decision

25d

Days

Class 2

Risk

About This 510(k) Submission

K241399 is an FDA 510(k) clearance for the Indigo? Lightning Flash Aspiration System ? Select +? Catheter, 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 June 10, 2024, 25 days after receiving the submission on May 16, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K241399 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 16, 2024
Decision Date	June 10, 2024
Days to Decision	25 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.