Cleared Special

K210195 - Triever Catheters

K210195 is the FDA 510(k) clearance for Triever Catheters by Inari Medical. It is a Class 2 Cardiovascular device (product code QEW) cleared through the Special 510(k) pathway after a 30-day FDA review.

K210195 · Inari Medical · Cardiovascular device
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Feb 2021
Decision
30d
Days
Class 2
Risk

K210195 is an FDA 510(k) clearance for the Triever Catheters. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Inari Medical (Irvine, US). The FDA issued a Cleared decision on February 24, 2021 after a review of 30 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.

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Submission Details

510(k) Number K210195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2021
Decision Date February 24, 2021
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
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 126
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K210195.
ClotTriever Thrombectomy System
K210689 · Inari Medical, Inc. · May 2021
FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24
K211013 · Inari Medical, Inc. · Apr 2021
Indigo Aspiration System - Lightning Aspiration Tubing
K210323 · Penumbra, Inc. · Feb 2021
ClotTriever Thrombectomy System
K210190 · Irani Medical, Inc. · Feb 2021
Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7
K210083 · Penumbra, Inc. · Feb 2021
NeVa PV Thrombectomy Device
K201085 · Vesalio · Jan 2021