510(k) K253715 ยท PIF Gastrointestinal Tubes With Enteral Specific Connectors
Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16F
| Applicant | Maquet Critical Care AB, Solna, SE |
| Decision | Substantially Equivalent, Aug 26, 2026 |
| Received | Nov 24, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253715
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.