SmartGUIDE deflectable hydrophilic guidewire— 510(k) K222690

Name: FDA 510(k) clearance K222690
Creator: U.S. Food and Drug Administration
Published: 2023-04-24

Substantially Equivalent

Artiria Medical SA

FDA 510(k) clearance K222690 for SmartGUIDE deflectable hydrophilic guidewire, Substantially Equivalent on 2023-04-24. Applicant: Artiria Medical SA. Device class: 2.

Clearance details

Applicant: Artiria Medical SA
Product code: Code MOF
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2022-09-06
Decision date: 2023-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Geneva, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code MOF

view all

K260751 — 35 Helix Guidewire2026-08-27
K262424 — Willow 12 Guidewire2026-08-14
K260223 — Aristotle Mini Guidewire2026-08-06
K254006 — Drivewire 35 Guidewire2026-07-17
K253579 — Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire2026-04-29

Adverse events under product code MOF

product code MOF

Death: 6
Injury: 137
Total: 143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.