Zenith Micro Guidewire— 510(k) K252317
Substantially EquivalentSuzhou 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.
Summary
Suzhou Zenith Vascular SciTech's Zenith Micro Guidewire is filed under product code MOF (Guide, Wire, Catheter, Neurovasculature).
Class II, 21 CFR 870.1330. The Neurology review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.
Suzhou Zenith Vascular SciTech filed from Suzhou, China. The decision came 265 calendar days after FDA received it (July 25, 2025 to April 16, 2026).
Clearance details
- Applicant
- Suzhou Zenith Vascular SciTech Limited
- Product code
- Product code MOF
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suzhou, CN
Recent devices under product code MOF
view allMore clearances from Suzhou Zenith Vascular SciTech Limited
view allAdverse events under product code MOF
product code MOF- Death
- 6
- Injury
- 137
- Total
- 143
Source: openFDA MAUDE database, through . 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.