K243534
- 510(k) number
- K243534
- Device name
- Micro Catheter
- Applicant
- Suzhou Zenith Vascular SciTech Limited CN
- Product code
- KRA — Catheter, Continuous Flush
- Decision date
- 2025-07-30
- Date received
- 2024-11-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243534.pdf
Official FDA record: K243534
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.