510(k) K052055 ยท LGZ Warmer, Thermal, Infusion Fluid
SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200
| Applicant | Smisson-Cartledge Biomedical, LLC, Alpharetta GA, US |
| Decision | Substantially Equivalent, Oct 26, 2006 |
| Received | Jul 29, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052055
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 26, 2021 | Smisson-Cartledge Biomedical, LLC ThermaCor 1200 Disposable Sets
Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including pa Terminated |
LGZ | None listed |
| Mar 26, 2021 | Smisson-Cartledge Biomedical, LLC ThermaCor 1200 Disposable Sets
Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including p Terminated |
LGZ | None listed |
| Mar 26, 2021 | Smisson-Cartledge Biomedical, LLC ThermaCor 1200 Disposable Sets
Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including p Terminated |
LGZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.