Suzhou Zenith Vascular Scitech Limited
Suzhou Jiangsu, CN
SUZHOU ZENITH VASCULAR SCITECH LIMITED appears in FDA device records in Suzhou Jiangsu, CN. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Suzhou Zenith Vascular Scitech Limited between 2025 and 2026. The busiest year on record is 2026, with 3. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2025 | 1 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253359 | Zenith Distal Access Long Sheath | QJP | Substantially Equivalent | |
| K252707 | Zenith Aspiration Catheter; Disposable Aspiration Tubing Set | NRY | Substantially Equivalent | |
| K252317 | Zenith Micro Guidewire | MOF | Substantially Equivalent | |
| K243534 | Micro Catheter | KRA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3039020025 | 3039020025 | SUZHOU ZENITH VASCULAR SCITECH LIMITED | Ground Floor to 5th Floor, Underground Unit B102, Building 6, Block B, Phase 5, Biobay, Suzhou Jiangsu 215123 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain