MRIDIUM 3850 MRI PUMP SYSTEM
FDA 510(k) clearance K050301 · decided 2005-03-24
Clearance details
- K-number
- K050301
- Device name
- MRIDIUM 3850 MRI PUMP SYSTEM
- Applicant
- Iradimed Corporation
- Decision
- Substantially Equivalent
- Date received
- 2005-02-08
- Decision date
- 2005-03-24
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Winter Park, FL, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Ada recall (Z-1310-2023) | Iradimed Corporation | 2023-03-30 |
| The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot recall (Z-0446-2013) | Iradimed Corporation | 2012-11-28 |