510(k) K252652 ยท DXT Injector And Syringe, Angiographic
Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Acc
| Applicant | Fortis Biosolutions Company Limited, Taoyuan City, TW |
| Decision | Substantially Equivalent, May 14, 2026 |
| Received | Aug 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252652
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.