Cleared Traditional

K193462 - ClotTriever Thrombectomy System

K193462 is the FDA 510(k) clearance for ClotTriever Thrombectomy System by Inari Medical. It is a Class 2 Cardiovascular device (product code QEW) cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K193462 · Inari Medical · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Sep 2020
Decision
268d
Days
Class 2
Risk

K193462 is an FDA 510(k) clearance for the ClotTriever Thrombectomy 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 September 9, 2020 after a review of 268 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.

View all Inari Medical devices

Submission Details

510(k) Number K193462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2019
Decision Date September 09, 2020
Days to Decision 268 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
143d slower than avg
Panel avg: 125d · This submission: 268d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03575364 Completed Observational Industry-sponsored

ClotTriever Outcomes (CLOUT) Registry

499
Patients (actual)
43
Sites
Condition studied Deep Vein Thrombosis Leg; DVT; Chronic DVT of Lower Extremity; Acute DVT of Lower Extremity
Eligibility All sexes · 18 Years+
Principal investigator David Dexter, MD
Sponsor Inari Medical (industry)
Started 2018-09-01 → Primary completion 2022-03-25 → Completed 2024-07-02
Primary outcome
Primary Safety Endpoint: Proportion Participants With Major Adverse Events
Secondary outcome
Primary Effectiveness Endpoint (Primary Effectiveness Cohort): Participants With Complete or Near Complete (≥75%) Removal of Venous Thrombus
View full study on ClinicalTrials.gov

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 K193462.
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
Indigo Aspiration System - Aspiration Catheter 7 and Separator 7
K193595 · Penumbra, Inc. · Aug 2020
CAPERE Thrombectomy System
K201216 · Vascular Medcure, Inc. · Jul 2020
Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12
K192981 · Penumbra, Inc. · May 2020