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
07640142811305Guidewire 0.025 6/270cm angled Straub Medical AGDQX2022-06-30
07640142811312SET Aspirex™ S 6F 110cmStraub Medical AGDQX2022-06-30
07640142811329SET Aspirex™ S 6F 135cmStraub Medical AGDQX2022-06-30
07640142811336SET Aspirex™ S 8F 85cmStraub Medical AGDQX2022-06-30
07640142811343SET Aspirex™ S 8F 110cmStraub Medical AGDQX2022-06-30
07640142811350SET Aspirex™ S 10F 110cmStraub Medical AGDQX2022-06-30
07640142811855SET Rotarex™S 6 F x 110 cmStraub Medical AGDQX2022-05-04
07640142811862SET Rotarex™S 6 F x 135 cm Straub Medical AGDQX2022-05-04
07640142811879SET Rotarex™S 8 F x 85 cm Straub Medical AGDQX2022-05-04
07640142811886SET Rotarex™S 8 F x 110 cmStraub Medical AGDQX2022-05-04
07613327508499Synchro SELECTStryker CorporationDQX2020-10-20
07613327508505Synchro SELECTStryker CorporationMOF2020-10-20
07613327508512Synchro SELECTStryker CorporationDQX2020-10-20
07613327508529Synchro SELECTStryker CorporationDQX2020-10-20
07613327508574Synchro SELECTStryker CorporationMOF2020-10-20
07613327508581Synchro SELECTStryker CorporationDQX2020-10-20
07613327508598Synchro SELECTStryker CorporationMOF2020-10-20
07613327508604Synchro SELECTStryker CorporationMOF2020-10-20
07613327508611Synchro SELECTStryker CorporationMOF2020-10-20
07613327508628Synchro SELECTStryker CorporationDQX2020-10-20
07613327508635Synchro SELECTStryker CorporationDQX2020-10-20
07613327508642Synchro SELECTStryker CorporationMOF2020-10-20
07640142810575SET Rotarex®S 6F 110cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07640142810582SET Rotarex®S 6F 135cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07640142810599SET Rotarex®S 8F 85cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07640142810605SET Rotarex®S 8F 110 cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07613327459630Synchro2Stryker CorporationMOF2019-06-20
07613327459647Synchro2Stryker CorporationDQX2019-06-20
07613327459654Synchro2Stryker CorporationMOF2019-06-20
07613327459661Synchro2Stryker CorporationDQX2019-06-20