510(k) K252423 ยท FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
NovaLine Tubing Set for Hemodialysis (BL 124)
| Applicant | Bain Medical Equipment (Guangzhou) Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, May 15, 2026 |
| Received | Aug 1, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252423
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.