FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Zenith Micro Guidewire
K Number: K252317
·
Decision Apr 16, 2026
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
39
Applicant Total
4
Review Days
265
Basic Information
- Device Name
- Zenith Micro Guidewire
- K Number
- K252317
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Suzhou Zenith Vascular SciTech Limited
- Date Received
- July 25, 2025
- Decision Date
- April 16, 2026
- Product Code
- MOF
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MOF | Guide, Wire, Catheter, Neurovasculature | FDA class 2 | Cardiovascular |
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