FDA.reportPublic FDA data

SmartGUIDE deflectable hydrophilic guidewire

Primary DI
07649989542021
Brand
SmartGUIDE deflectable hydrophilic guidewire
Company
Artiria Medical SA
Model
ASM-0001-1
Catalog number
ASM-0001
Published
2026-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQXWire, Guide, Catheter
MOFGuide, Wire, Catheter, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2
MOFGuide, Wire, Catheter, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222690000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222690000SmartGUIDE deflectable hydrophilic guidewireArtiria Medical SA2023-04-24MOF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07649989542021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07649989542021076499895420217649989542021

GMDN Terms#

Term, Definition table
TermDefinition
Neurovascular guidewireA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480422032
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450529348SplashWire™Merit Medical Systems, Inc.DQX2026-07-07
06947358524021Sunmed™ guide wiresSunny Medical Device (Shenzhen) Co., Ltd.DQX2026-07-07
06947358535454Sunmed™ guide wiresSunny Medical Device (Shenzhen) Co., Ltd.DQX2026-07-07
06971428595857DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595857DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.MOF2026-07-03
06971428595864DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595864DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.MOF2026-07-03
06971428595871DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.MOF2026-07-03
06971428595871DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595888DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595888DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.MOF2026-07-03
06971428595895DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595895DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.MOF2026-07-03
06971428595901DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595901DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.MOF2026-07-03
06971428595918DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.MOF2026-07-03
06971428595918DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595925DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595925DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.MOF2026-07-03
00816349014994CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015007CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015014CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015021CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015038CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015045CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015052CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015069CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015076CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015083CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349012570Safari2Lake Region MedicalDQX2026-06-25