Cleared Traditional

INDIGO? Aspiration System - Lightning Flash Aspiration Tubing with LINK

K251949 · Penumbra, Inc. · Cardiovascular

Feb 2026

Decision

225d

Days

Class 2

Risk

About This 510(k) Submission

K251949 is an FDA 510(k) clearance for the INDIGO? Aspiration System - Lightning Flash Aspiration Tubing with LINK, 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 5, 2026, 225 days after receiving the submission on June 25, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K251949 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 25, 2025
Decision Date	February 05, 2026
Days to Decision	225 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.