Cleared Special

K200771 - Indigo Aspiration System Lightning Aspi...

K200771 is the FDA 510(k) clearance for Indigo Aspiration System Lightning Aspi... by Penumbra, Inc.. It is a Class 2 Cardiovascular device (product code QEW) cleared through the Special 510(k) pathway after a 28-day FDA review.

K200771 · Penumbra, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
28d
Days
Class 2
Risk

K200771 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 April 22, 2020 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Penumbra, Inc. devices

Submission Details

510(k) Number K200771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2020
Decision Date April 22, 2020
Days to Decision 28 days
Submission Type Special
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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K200771.
CAPERE Thrombectomy System
K201216 · Vascular Medcure, Inc. · Jul 2020
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
K193244 · Penumbra, Inc. · Mar 2020
Capere Thrombectomy System
K200314 · Vascular Medcure, Inc. · Mar 2020
Indigo Aspiration System
K192833 · Penumbra, Inc. · Dec 2019