Cleared Traditional

Indigo? Aspiration System ? Lightning Bolt Aspiration Tubing

K242075 · Penumbra, Inc. · Cardiovascular

Sep 2024

Decision

71d

Days

Class 2

Risk

About This 510(k) Submission

K242075 is an FDA 510(k) clearance for the Indigo? Aspiration System ? Lightning Bolt 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 September 25, 2024, 71 days after receiving the submission on July 16, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K242075 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 16, 2024
Decision Date	September 25, 2024
Days to Decision	71 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.