K252122
- 510(k) number
- K252122
- Device name
- DCwire Micro-guidewire
- Applicant
- Shanghai Achieva Medical Suzhou Co., Ltd. CN
- Product code
- MOF — Guide, Wire, Catheter, Neurovasculature
- Decision date
- 2026-03-16
- Date received
- 2025-07-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K252122.pdf
Official FDA record: K252122
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.