MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY
FDA 510(k) clearance K073051 · decided 2008-05-30
Clearance details
- K-number
- K073051
- Device name
- MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY
- Applicant
- Medrad, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-10-29
- Decision date
- 2008-05-30
- Days to decision
- 214 days
- Clearance type
- Abbreviated
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Indianola, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion recall (Z-1673-2014) | Bayer Corp | 2014-05-30 |
| Medrad(R) Continuum MR Infusion Pump Peristaltic Pump System designed for patients who req recall (Z-0595-2013) | Medrad Inc | 2012-12-20 |