510(k) K050301 ยท FRN Pump, Infusion
MRIDIUM 3850 MRI PUMP SYSTEM
| Applicant | Iradimed Corporation, Winter Park FL, US |
| Decision | Substantially Equivalent, Mar 24, 2005 |
| Received | Feb 8, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050301
| 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 |
| Nov 28, 2012 | Iradimed Corporation The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001. The generic name is infusion administration set.
Labeling indicates ~10 ml, Latex-free Infusio Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.