510(k) K253048 ยท DXT Injector And Syringe, Angiographic
High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube
| Applicant | Shenzhen Maiwei Biotech Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Apr 16, 2026 |
| Received | Sep 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253048
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.