Cleared Special

ClotTriever Thrombectomy System (K210190) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway.

K210190 · Irani Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2021
Decision
29d
Days
Class 2
Risk

K210190 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 Irani Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on February 23, 2021 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.

View all Irani Medical, Inc. devices

Submission Details

510(k) Number K210190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2021
Decision Date February 23, 2021
Days to Decision 29 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
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. 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 120
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K210190.
FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24
K211013 · Inari Medical, Inc. · Apr 2021
Indigo Aspiration System - Lightning Aspiration Tubing
K210323 · Penumbra, Inc. · Feb 2021
Triever Catheters
K210195 · Inari Medical · Feb 2021
Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7
K210083 · Penumbra, Inc. · Feb 2021
NeVa PV Thrombectomy Device
K201085 · Vesalio · Jan 2021
ReVene Thrombectomy Catheter
K201705 · Vetex Medical, Ltd. · Dec 2020