Suzhou Zenith Vascular SciTech Limited
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 4
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253359 | Zenith Distal Access Long Sheath | May 22, 2026 |
| K252707 | Zenith Aspiration Catheter; Disposable Aspiration Tubing Set | May 20, 2026 |
| K252317 | Zenith Micro Guidewire | April 16, 2026 |
| K243534 | Micro Catheter | July 30, 2025 |