Cleared Traditional

K201541 - FlowTriever Retrieval/Aspiration System

K201541 is the FDA 510(k) clearance for FlowTriever Retrieval/Aspiration System by Inari Medical. It is a Class 2 Cardiovascular device (product code QEW) cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K201541 · Inari Medical · Cardiovascular device
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Dec 2020
Decision
178d
Days
Class 2
Risk

K201541 is an FDA 510(k) clearance for the FlowTriever Retrieval/Aspiration System. 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 December 4, 2020 after a review of 178 days - an extended review cycle.

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.

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Submission Details

510(k) Number K201541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2020
Decision Date December 04, 2020
Days to Decision 178 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
53d slower than avg
Panel avg: 125d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K201541.
CAPERE Thrombectomy System
K203476 · Vascular Medcure, Inc. · Dec 2020
FlowTriever Retrieval/Aspiration System
K202345 · Inari Medical · Dec 2020
Triever20 Curve Catheter
K203333 · Inari Medical, Inc. · Dec 2020
Indigo Aspiration System - Aspiration Catheter 12 and Separator 12
K202821 · Penumbra, Inc. · Nov 2020
ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device
K202218 · Boston Scientific Corporation · Oct 2020
Pounce Thrombus Retrieval System
K192814 · Surmodics,Inc. · Sep 2020