FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
DCwire Micro-guidewire
K Number: K252122
·
Decision Mar 16, 2026
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
39
Applicant Total
1
Review Days
252
Basic Information
- Device Name
- DCwire Micro-guidewire
- K Number
- K252122
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shanghai Achieva Medical Suzhou Co., Ltd.
- Date Received
- July 7, 2025
- Decision Date
- March 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MOF), ordered by most recent decision date.
Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
Zenith Micro Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
Willow 24 Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
Willow 18 Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
CHIKAI Nexus petit
FDA 510(k)
FDA Class 2
·Cardiovascular
0.014 Willow Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular