Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Suzhou Zenith Vascular SciTech Limited

FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories4
Latest FDA decision2026-05-22
TypeNumberDevice NameCodeDateActions
510(k) K253359 Zenith Distal Access Long SheathQJP2026-05-22 View
510(k) K252707 Zenith Aspiration Catheter; Disposable Aspiration Tubing SetNRY2026-05-20 View
510(k) K252317 Zenith Micro GuidewireMOF2026-04-16 View
510(k) K243534 Micro CatheterKRA2025-07-30 View