510(k) K190502 ยท PNR Enteral Syringes With Enteral Specific Connectors
ENFit Oral / Enteral Syringe
| Applicant | Jiangsu Caina Medical Co.,Ltd, Jiangyin, CN |
| Decision | Substantially Equivalent, Aug 6, 2019 |
| Received | Mar 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190502
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2024 | Cardinal Health 200, LLC Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE Open, Classified |
PNR | None listed |
| Feb 2, 2024 | Cardinal Health 200, LLC Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit
Connection System, REF 412SE Open, Classified |
PNR | None listed |
| Feb 2, 2024 | Cardinal Health 200, LLC Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE Open, Classified |
PNR | None listed |
| Feb 2, 2024 | Cardinal Health 200, LLC Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit
Connection System, REF 460SE Open, Classified |
PNR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.