Cleared Traditional

K223000 - Artix BG

K223000 is the FDA 510(k) clearance for Artix BG by Inari Medical. It is a Class 2 Cardiovascular device (product code QEW) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K223000 · Inari Medical · Cardiovascular device
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Jan 2023
Decision
105d
Days
Class 2
Risk

K223000 is an FDA 510(k) clearance for the Artix BG. 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 January 11, 2023 after a review of 105 days - within the typical 510(k) review window.

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.

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Submission Details

510(k) Number K223000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2022
Decision Date January 11, 2023
Days to Decision 105 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
20d faster than avg
Panel avg: 125d · This submission: 105d
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 125
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K223000.
Cobra Catheter System
K223891 · Endovascular Engineering · Feb 2023
Indigo® Aspiration System – Lightning Bolt Aspiration Tubing
K223186 · Penumbra, Inc. · Feb 2023
ClotTriever Thrombectomy System
K221531 · Inari Medical, Inc. · Feb 2023
Indigo Aspiration System - Lightning Flash
K222358 · Penumbra, Inc. · Dec 2022
WOLF Thrombectomy™ SmartClaw Catheter
K221391 · Devoro Medical, Inc. · Nov 2022
INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)
K220683 · Penumbra, Inc. · Oct 2022