Cleared Traditional

K241894 - Artix™ MT

Also marketed or referenced as:
Artix™ Thin-Walled Thrombectomy Sheath

K241894 is an FDA 510(k) clearance for Artix MT, manufactured by Inari Medical, Inc.. The device is a Class 2 Cardiovascular device with product code QEW cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K241894 · Inari Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
109d
Days
Class 2
Risk

K241894 is an FDA 510(k) clearance for the Artix™ MT. 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 October 15, 2024 after a review of 109 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.

View all Inari Medical, Inc. devices

FDA 510(k) Submission Details - K241894

510(k) Number K241894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2024
Decision Date October 15, 2024
Days to Decision 109 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
16d faster than avg
Panel avg: 125d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QEW Device Classification - Class 2, Special Controls

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 136
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K241894.
Aventus Thrombectomy System (IM-2100)
K250668 · Inquis Medical · Mar 2025
FlowTriever2 Catheter
K250088 · Inari Medical, Inc. · Mar 2025
Aventus Thrombectomy System
K250202 · Inquis Medical · Feb 2025
ClotTriever XL Catheter (41-102)
K242557 · Inari Medical, Inc. · Sep 2024
Indigo® Aspiration System – Lightning Bolt Aspiration Tubing
K242075 · Penumbra, Inc. · Sep 2024
Pounce XL Thrombectomy System (PTS-1011-7F135)
K241362 · Surmodics,Inc. · Sep 2024