# Suzhou Zenith Vascular SciTech Limited

- Location (FDA's records): Suzhou, CN
- FDA decisions: 4 (2025–2026): 4 510(k) clearances
- Product codes: MOF (1), KRA (1), NRY (1), QJP (1)
- 510(k) review time since 2016: median 265 days, against 147 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 7 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Penumbra, Inc.: 4 (https://510kreport.com/company/penumbra)
- MicroVention, Inc.: 1 (https://510kreport.com/company/microvention)
- Scientia Vascular, LLC: 1 (https://510kreport.com/company/scientia-vascular)
- Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular: 1 (https://510kreport.com/company/micro-therapeuatics-d-b-a-ev3-neurovascular)

## Recent decisions
- K253359: Zenith Distal Access Long Sheath (May 22, 2026)
- K252707: Zenith Aspiration Catheter; Disposable Aspiration Tubing Set (May 20, 2026)
- K252317: Zenith Micro Guidewire (Apr 16, 2026)
- K243534: Micro Catheter (Jul 30, 2025)

Source page: https://510kreport.com/company/suzhou-zenith-vascular-scitech