Cleared Traditional

INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)

K220683 · Penumbra, Inc. · Cardiovascular

Oct 2022

Decision

210d

Days

Class 2

Risk

About This 510(k) Submission

K220683 is an FDA 510(k) clearance for the INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4), 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 October 4, 2022, 210 days after receiving the submission on March 8, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K220683 FDA.gov
FDA Decision	Cleared SESU
Date Received	March 08, 2022
Decision Date	October 04, 2022
Days to Decision	210 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.