Cleared Special

K230912 - Artix BG

K230912 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 Special 510(k) pathway after a 32-day FDA review.

K230912 · Inari Medical · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 2023
Decision
32d
Days
Class 2
Risk

K230912 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 May 2, 2023 after a review of 32 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.

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Submission Details

510(k) Number K230912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2023
Decision Date May 02, 2023
Days to Decision 32 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
93d faster than avg
Panel avg: 125d · This submission: 32d
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 125
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K230912.
Pounce™ Thrombectomy System
K231022 · Surmodics,Inc. · Jun 2023
Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System)
K223929 · Innova Vascular, Inc. · Jun 2023
Excipio SV Aspiration Catheter and Tubing
K230030 · Contego Medical, Inc. · May 2023
ClotTriever XL Catheter
K223210 · Inari Medical, Inc. · Apr 2023
ClotTriever BOLD Catheter
K230494 · Inari Medical, Inc. · Apr 2023
ROVO Mechanical Thrombectomy Device
K220780 · 2mg, Inc. · Mar 2023