Cleared Traditional

K193244 - Indigo Aspiration System – Lightning As...

K193244 is the FDA 510(k) clearance for Indigo Aspiration System – Lightning As... by Penumbra, Inc.. It is a Class 2 Cardiovascular device (product code QEW) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K193244 · Penumbra, Inc. · Cardiovascular device
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Mar 2020
Decision
109d
Days
Class 2
Risk

K193244 is an FDA 510(k) clearance for the Indigo Aspiration System – Lightning Aspiration Tubing. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on March 13, 2020 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Penumbra, Inc. devices

Submission Details

510(k) Number K193244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2019
Decision Date March 13, 2020
Days to Decision 109 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 125d · This submission: 109d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QEW Peripheral Mechanical Thrombectomy With Aspiration
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03218566 Completed Interventional Industry-sponsored

Evaluating the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism

A Prospective, Multicenter Trial to Evaluate the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism

119
Patients (actual)
22
Sites
Treatment
Purpose
Open label
Masking
Condition studied Pulmonary Embolism
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Akhilesh Sista, MD
Sponsor Penumbra Inc. (industry)
Started 2017-11-22 → Primary completion 2019-03-10 → Completed 2019-04-05
Primary outcome
Right Ventricle/Left Ventricle (RV:LV) Ratio
Secondary outcome
Device-related Death Rate
View full study on ClinicalTrials.gov

Regulatory Peers - QEW Peripheral Mechanical Thrombectomy With Aspiration

All 125
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K193244.
Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12
K192981 · Penumbra, Inc. · May 2020
WOLF Thrombectomy V System
K200101 · Devoro Medical, Inc. · Apr 2020
Indigo Aspiration System Lightning Aspiration Tubing
K200771 · Penumbra, Inc. · Apr 2020
Capere Thrombectomy System
K200314 · Vascular Medcure, Inc. · Mar 2020
Indigo Aspiration System
K192833 · Penumbra, Inc. · Dec 2019
CAPERE Thrombectomy System
K192935 · Vascular Medcure, Inc. · Nov 2019