Cleared Special

ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath (K173470) - FDA 510(k) Clearance

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

K173470 · Inari Medical · Cardiovascular device
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Dec 2017
Decision
26d
Days
Class 2
Risk

K173470 is an FDA 510(k) clearance for the ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath. 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, 2017 after a review of 26 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 devices

Submission Details

510(k) Number K173470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2017
Decision Date December 04, 2017
Days to Decision 26 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
99d faster than avg
Panel avg: 125d · This submission: 26d
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 121
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K173470.
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
ZelanteDVT Thrombectomy Set
K151313 · Boston Scientific Corporation · Sep 2015
ReVive PV (Peripheral Vasculature) Thrombectomy Device
K132281 · Codman & Shurtleff, Inc. · Aug 2013
ANGIOJET ULTRA POWER PULSE KIT
K130381 · Medrad, Inc. · Jul 2013