510(k) K253359 ยท QJP Catheter, Percutaneous, Neurovasculature
Zenith Distal Access Long Sheath
| Applicant | Suzhou Zenith Vascular SciTech Limited, Suzhou, CN |
| Decision | Substantially Equivalent, May 22, 2026 |
| Received | Sep 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253359
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.