Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Suzhou Zenith Vascular SciTech Limited · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253359 | Zenith Distal Access Long Sheath | Suzhou Zenith Vascular SciTech Limited | 2026-05-22 | 234 | 0 |
| K252707 | Zenith Aspiration Catheter; Disposable Aspiration Tubing Set | Suzhou Zenith Vascular SciTech Limited | 2026-05-20 | 266 | 0 |
| K252317 | Zenith Micro Guidewire | Suzhou Zenith Vascular SciTech Limited | 2026-04-16 | 265 | 0 |
| K243534 | Micro Catheter | Suzhou Zenith Vascular SciTech Limited | 2025-07-30 | 257 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda