35 Helix Guidewire— 510(k) K260751

Name: FDA 510(k) clearance K260751
Creator: U.S. Food and Drug Administration
Published: 2026-08-27

Substantially Equivalent

Piraeus Medical, Inc.

FDA 510(k) clearance K260751 for 35 Helix Guidewire, Substantially Equivalent on 2026-08-27. Applicant: Piraeus Medical, Inc.. Device class: 2.

Clearance details

Applicant: Piraeus Medical, Inc.
Product code: Code MOF
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2026-03-06
Decision date: 2026-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MOF

view all

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
K252317 — Zenith Micro Guidewire2026-04-16

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.