510(k) K252355 ยท PTI Non-Coring (Huber) Needle
K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing
| Applicant | Sb-Kawasumi Laboratories, Inc., Kanagawa, JP |
| Decision | Substantially Equivalent, Nov 26, 2025 |
| Received | Jul 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252355
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.