FDA.report

510(k) K222690

Device
SmartGUIDE deflectable hydrophilic guidewire
Applicant
Artiria Medical SA
510(k) number
K222690
Product code
MOF
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-24
Date received
2022-09-06
Regulation
870.1330
Classification name
Guide, Wire, Catheter, Neurovasculature
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Guillaume Petit-Pierre
Address
Campus Biotech B3 N06 Chemin Des Mines 9 Geneva CH CH-1202 CH-1202

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
07649989542021SmartGUIDE deflectable hydrophilic guidewire Artiria Medical SA2026-03-02

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