Zenith Micro Guidewire— 510(k) K252317

Name: FDA 510(k) clearance K252317
Creator: U.S. Food and Drug Administration
Published: 2026-04-16

Substantially Equivalent

Suzhou Zenith Vascular SciTech Limited

FDA 510(k) clearance K252317 for Zenith Micro Guidewire, Substantially Equivalent on 2026-04-16. Applicant: Suzhou Zenith Vascular SciTech Limited. Device class: 2.

Clearance details

Applicant: Suzhou Zenith Vascular SciTech Limited
Product code: Code MOF
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2025-07-25
Decision date: 2026-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code MOF

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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

More clearances from Suzhou Zenith Vascular SciTech Limited

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K253359 — Zenith Distal Access Long Sheath2026-05-22
K252707 — Zenith Aspiration Catheter; Disposable Aspiration Tubing Set2026-05-20
K243534 — Micro Catheter2025-07-30

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.