Cleared Special

Indigo? Aspiration System ? Aspiration Catheter 6X

K242319 · Penumbra, Inc. · Cardiovascular

Sep 2024

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K242319 is an FDA 510(k) clearance for the Indigo? Aspiration System ? Aspiration Catheter 6X, 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 3, 2024, 29 days after receiving the submission on August 5, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K242319 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 05, 2024
Decision Date	September 03, 2024
Days to Decision	29 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.