510(k) K150034 ยท PIO Enteral Specific Transition Connectors
AMT Enteral Transition Adapters
| Applicant | Applied Medical Technology, Inc., Brecksville OH, US |
| Decision | Substantially Equivalent, Jun 9, 2015 |
| Received | Jan 9, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150034
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 10, 2020 | Applied Medical Technology Inc AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102.
Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)23 Terminated |
PIO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.