510(k) K001368 ยท LHI Set, I.V. Fluid Transfer
PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER
| Applicant | Carmel Pharma Ab., Gothenburg, SE |
| Decision | Substantially Equivalent, May 12, 2000 |
| Received | May 1, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001368
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2007 | Carmel Pharma, Inc. PhaSeal, Protector 14, Item No. P14, US Order No. 21320 Terminated |
FPA | None listed |
| Aug 22, 2007 | Carmel Pharma, Inc. PhaSeal Injector Luer Lock, Item No. 31, US Order No. 10310 Terminated |
FPA | None listed |
| Aug 22, 2007 | Carmel Pharma, Inc. PhaSeal, Protector 21, Item No. 21, US Order No. 22020 Terminated |
FPA | None listed |
| Aug 22, 2007 | Carmel Pharma, Inc. PhaSeal, Protector 50, Item No. 50, US Order No. 10310 Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.