FDA Registration
Inactive
🇨🇳 China
SUZHOU ZENITH VASCULAR SCITECH LIMITED
·
Expires 2026
Products
6
Proprietary Names
4
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- SUZHOU ZENITH VASCULAR SCITECH LIMITED
- Status
- Inactive
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Unit101, Building 6, Block B, Phase 5, Biobay, No.21 Dongyanli Road, SIP Suzhou
- City
- Suzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K243534
Owner / Operator
- Firm Name
- Suzhou Zenith Vascular SciTech Limited
- Operator Number
- 10095913
- Address
- Unit101, Building 6, Block B, Phase 5, Biobay, No.21 Dongyanli Road, SIP Suzhou
- City
- Suzhou
- State
- Jiangsu
- Postal Code
- 215123
- Country
- CN
- Correspondent
- Xiaoyu Wang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2026-05-21 |
| Catheter, Percutaneous, Neurovasculature | QJP | Class 2 | Cardiovascular | No | 2026-05-21 |
| Catheter, Thrombus Retriever | NRY | Class 2 | Cardiovascular | No | 2026-06-07 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2026-06-07 |
| Guide, Wire, Catheter, Neurovasculature | MOF | Class 2 | Cardiovascular | No | 2026-05-21 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2026-05-21 |
Proprietary Names
Micro Catheter
Zenith Aspiration Catheter; Disposable Aspiration Tubing Set
Zenith Distal Access Long Sheath
Zenith Micro Guidewire
Establishment Types
Manufacture Medical Device