OPTIFLUX F250NR, MODEL 0500325E
FDA 510(k) clearance K082414 · decided 2008-10-28
Clearance details
- K-number
- K082414
- Device name
- OPTIFLUX F250NR, MODEL 0500325E
- Applicant
- Fresenius Medical Care North America
- Decision
- Substantially Equivalent
- Date received
- 2008-08-21
- Decision date
- 2008-10-28
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- KDI
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute or chronic hemana recall (Z-1105-2014) | Fresenius Medical Care Holdings, Inc. | 2014-02-26 |
| Fresenius Optiflux F250NRe Hemodialyzer, , intended for single use in acute and chronic he recall (Z-0825-2012) | Fresenius Medical Care Holdings, Inc. | 2012-01-20 |
| Fresenius Optiflux F250NRe Hemodialyzer, Single Use, Catalog Number: 0500325E, Advanced Fr recall (Z-1622-2011) | Fresenius Medical Care Holdings, Inc. | 2011-03-22 |