510(k) K190923 ยท PIF Gastrointestinal Tubes With Enteral Specific Connectors
Salem Sump Dual Lumen Stomach Tube with ENFit Connection
| Applicant | Cardinalhealth, Mansfield MA, US |
| Decision | Substantially Equivalent, Nov 7, 2019 |
| Received | Apr 9, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190923
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 17, 2025 | Cardinal Health 200, LLC Salem Sump PVC Tubes:
Product Code/Product Name:
8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN
8888264929E ENFit" SALEM SUMP" PVC TUBE 12FR 48IN
8888264945E ENFit" SALEM SUMP" PVC TUBE 14FR 48IN Open, Classified |
FEG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.