Cleared Traditional

K223210 - ClotTriever XL Catheter (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223210 · Inari Medical, Inc. · Cardiovascular device
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Apr 2023
Decision
192d
Days
Class 2
Risk

K223210 is an FDA 510(k) clearance for the ClotTriever XL Catheter. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Inari Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on April 27, 2023 after a review of 192 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, Inc. devices

Submission Details

510(k) Number K223210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2022
Decision Date April 27, 2023
Days to Decision 192 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
67d slower than avg
Panel avg: 125d · This submission: 192d
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 140
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K223210.
INDIGO® Aspiration System – INDIGO Link
K260599 · Penumbra, Inc. · Apr 2026
INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
K251949 · Penumbra, Inc. · Feb 2026
CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister
K260028 · Argon Medical Devices, Inc. · Feb 2026
RoVo Mechanical Thrombectomy System
K253730 · Verge Medical, Inc. · Jan 2026
Sangria™ Thrombectomy System
K251207 · Avantec Vascular Corporation · Jan 2026
Helo Thrombectomy System
K252956 · Endovascular Engineering, Inc. · Dec 2025