Suzhou Zenith Vascular Scitech Limited
Registered establishment in Suzhou, Jiangsu, China. 6 device types, 4 clearances.
Suzhou Zenith Vascular Scitech Limited is a manufacturer holding a current FDA establishment registration. The registration covers Wire, Guide, Catheter, Catheter, Percutaneous and 4 other device types. Its earliest product listing with the FDA dates from 2026.
6device types registered with the FDA
4510(k) clearances
Registration
| Registered name | SUZHOU ZENITH VASCULAR SCITECH LIMITED |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3039020025 |
| FEI number | 3039020025 |
| Establishment type | Manufacturer |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | Ground Floor to 5th Floor, Underground Unit B102, Building 6, Block B, Phase 5, Biobay |
| Postal code | 215123 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Catheter, Continuous Flush | Class 2 | Micro Catheter | 2026 | 5 |
| Catheter, Percutaneous | Class 2 | Zenith Distal Access Long Sheath | 2026 | 14 |
| Catheter, Percutaneous, Neurovasculature | Class 2 | Micro Catheter, Zenith Distal Access Long Sheath | 2026 | 6 |
| Catheter, Thrombus Retriever | Class 2 | Zenith Aspiration Catheter; Disposable Aspiration Tubing Set | 2026 | 5 |
| Guide, Wire, Catheter, Neurovasculature | Class 2 | Zenith Micro Guidewire | 2026 | 5 |
| Wire, Guide, Catheter | Class 2 | Zenith Micro Guidewire | 2026 | 10 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K253359 | 2026-05-22 | QJP | Traditional | This company |
| K252707 | 2026-05-20 | NRY | Traditional | This company |
| K252317 | 2026-04-16 | MOF | Traditional | This company |
| K243534 | 2025-07-30 | KRA | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2018 |
|---|---|
| Main products | Intracranial Aspiration Catheter, Stent Retriever, Navigation Microcatheter, Vascular interventional products |
| Certifications | NMPA |
| Export markets | Global |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.