Cleared Special

K162970 - FlowTriever Retrieval/Aspiration System

K162970 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 Special 510(k) pathway after a 29-day FDA review.

K162970 · Inari Medical · Cardiovascular device
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Nov 2016
Decision
29d
Days
Class 2
Risk

K162970 is an FDA 510(k) clearance for the FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retractio.... 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 November 22, 2016 after a review of 29 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 K162970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2016
Decision Date November 22, 2016
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
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 127
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K162970.
Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister
K180105 · Penumbra, Inc. · Mar 2018
FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter
K173672 · Inari Medical · Feb 2018
V2K Rinspiration System
K172716 · V2k Medical, Inc. · Jan 2018
Penumbra Aspiration System
K161506 · Penumbra, Inc. · Sep 2016
INDIGO Aspiration System
K161523 · Penumbra, Inc. · Jul 2016
Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)
K160533 · Penumbra, Inc. · May 2016