510(k) K090087 ยท FRN Pump, Infusion
MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM
| Applicant | Iradimed Corporation, Winter Park FL, US |
| Decision | Substantially Equivalent, Apr 7, 2009 |
| Received | Jan 13, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090087
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2023 | Iradimed Corporation Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50, Open, Classified |
FRN | None listed |
| Aug 2, 2013 | Iradimed Corporation MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System).
The MRidium 3860+MRI Infusion pump are intended for general hospital or Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.