510(k) K100798 ยท FRN Pump, Infusion
MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C
| Applicant | Medrad, Inc., Indianola PA, US |
| Decision | Substantially Equivalent, Jun 23, 2010 |
| Received | Mar 22, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100798
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 6, 2023 | Bayer Medical Care, Inc. Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile
Catalog number: INT CSS
Affected material number: 86566621
Intended to deliver accurate doses of 18F Fluorode Open, Classified |
FRN | None listed |
| Nov 11, 2016 | Bayer Healthcare PET Infusion Pump Terminated |
FRN | None listed |
| Jan 11, 2016 | Bayer Healthcare Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures. Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.