Cleared Special

Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7 (K210083) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K210083 · Penumbra, Inc. · Cardiovascular device
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Feb 2021
Decision
28d
Days
Class 2
Risk

K210083 is an FDA 510(k) clearance for the Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Li.... 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 February 9, 2021 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 K210083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2021
Decision Date February 09, 2021
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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - QEW Peripheral Mechanical Thrombectomy With Aspiration

All 120
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K210083.
Indigo Aspiration System - Lightning Aspiration Tubing
K210323 · Penumbra, Inc. · Feb 2021
Triever Catheters
K210195 · Inari Medical · Feb 2021
ClotTriever Thrombectomy System
K210190 · Irani Medical, Inc. · Feb 2021
NeVa PV Thrombectomy Device
K201085 · Vesalio · Jan 2021
ReVene Thrombectomy Catheter
K201705 · Vetex Medical, Ltd. · Dec 2020
CAPERE Thrombectomy System
K203476 · Vascular Medcure, Inc. · Dec 2020