Cleared Special

FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24 (K211013) - FDA 510(k) Clearance

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

K211013 · Inari Medical, Inc. · Cardiovascular device
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Apr 2021
Decision
25d
Days
Class 2
Risk

K211013 is an FDA 510(k) clearance for the FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, T.... Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Inari Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on April 30, 2021 after a review of 25 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 Inari Medical, Inc. devices

Submission Details

510(k) Number K211013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2021
Decision Date April 30, 2021
Days to Decision 25 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
100d faster than avg
Panel avg: 125d · This submission: 25d
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 K211013.
WOLF Thrombectomy System, 6F
K210530 · Devoro Medical, Inc. · Aug 2021
Pounce Thrombectomy System
K211492 · Surmodics,Inc. · Jul 2021
ClotTriever Thrombectomy System
K210689 · Inari Medical, Inc. · May 2021
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