SmartGUIDE deflectable hydrophilic guidewire

Basic Information

• Brand Name: SmartGUIDE deflectable hydrophilic guidewire
• Primary DI: 07649989542021
• Version / Model: ASM-0001-1
• Catalog Number: ASM-0001
• Company Name: Artiria Medical SA
• Labeler DUNS: 480422032
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-02
• Public Version: 1
• Public Version Date: 2026-03-10
• Public Version Status: New
• Public Device Record Key: ca0fb8ea-1e3d-48f6-9d19-ed861b2786fe

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• 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
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	870.1330	2
DQX	Wire, Guide, Catheter	Cardiovascular	870.1330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
67756	Neurovascular guidewire	A long, thin, non-powered, steerable wire intended to be percutaneously introduced into the neurovasculature anatomy to function as a guide for the introduction of interventional devices (e.g., microcatheter, embolization coil) for the treatment/management of neurovascular conditions (e.g., stroke, intracerebral haemorrhage). It features an atraumatic distal tip and manual steerable controls at the proximal end to facilitate navigation through intracranial tortuous vessels or across tight lesions. It may in addition be used in the peripheral vasculature; it is not intended for cardiac/coronary access. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07649989542021	GS1

Premarket Submissions

Submission Number	Supplement Number
K222690	000