Artix MT

Basic Information

• Brand Name: Artix MT
• Primary DI: 00810123710584
• Version / Model: 32-102 / AS-01248
• Company Name: Inari Medical, Inc.
• Labeler DUNS: 076827459
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-11
• Public Version: 2
• Public Version Date: 2026-02-09
• Public Version Status: Update
• Public Device Record Key: df4a6800-8592-4d44-8410-272d139bd7b4

Device Description

Artix MT (Thrombectomy Device)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KRA	Catheter, Continuous Flush	Cardiovascular	870.1210	2
DQY	Catheter, Percutaneous	Cardiovascular	870.1250	2
DYB	Introducer, Catheter	Cardiovascular	870.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61779	Thrombectomy wire-net	A device intended to be percutaneously introduced into the vasculature (coronary, peripheral and/or intracranial) through an appropriate intravascular catheter for the removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction; revascularization may also be achieved through thrombus reorientation. Also referred to as a stent retriever or clot retrieval catheter, it consists of an expanding, stent-like wire net connected to a pusher wire primarily intended to grip and remove the emboli/thrombi; it might include a guide-catheter dedicated to introduction of the wire-net. This is a single-use device.	No	Active
66423	Thrombectomy wire-net introduction set	A dedicated collection of manual invasive devices intended to provide percutaneous vascular access to enable the introduction, and safe retrieval, of a thrombectomy wire-net (not included) during a thrombectomy procedure. It includes a non-steerable sheath typically with an expanding distal funnel to facilitate wire-net retrieval, an obturator/dilator, a haemostatic valve to control blood loss, and a side port. It is typically also designed to allow removal of residual clotted blood, trapped in the sheath funnel upon retrieval, through manual suction (aspiration). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810123710584	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K241894	000