Cleared Traditional

INDIGO Aspiration System

K163618 · Penumbra, Inc. · Cardiovascular
May 2017
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K163618 is an FDA 510(k) clearance for the INDIGO Aspiration System, a Coronary Mechanical Thrombectomy With Aspiration (Class II — Special Controls, product code QEX), submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on May 24, 2017, 153 days after receiving the submission on December 22, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number K163618 FDA.gov
FDA Decision Cleared SESU
Date Received December 22, 2016
Decision Date May 24, 2017
Days to Decision 153 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code QEX — Coronary 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 Coronary Vasculature Through Aspiration.