FRESENIUS OPTIFLUX 200NR
FDA 510(k) clearance K002277 · decided 2000-08-25
Clearance details
- K-number
- K002277
- Device name
- FRESENIUS OPTIFLUX 200NR
- Applicant
- Fresenius Medical Care North America
- Decision
- Substantially Equivalent
- Date received
- 2000-07-26
- Decision date
- 2000-08-25
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- KDI
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lexington, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N. Single Use acute or chronic recall (Z-1099-2014) | Fresenius Medical Care Holdings, Inc. | 2014-02-26 |
| Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N. Single Use acute or chronic recall (Z-1101-2014) | Fresenius Medical Care Holdings, Inc. | 2014-02-26 |
| Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use acute or chronic recall (Z-1103-2014) | Fresenius Medical Care Holdings, Inc. | 2014-02-26 |
| Optiflux F180NR Dialyzers, Catalog Number: 0500318E. Manufactured by Fresenius Medical Car recall (Z-1951-2010) | Fresenius Medical Care North America | 2010-07-01 |
| Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius Medical Ca recall (Z-0738-2008) | Fresenius Medical Care North America | 2008-02-01 |
| Optiflux Series Fresenius Polysulfone F160NR dialyzer High Flux Catalog Number: 0500316N recall (Z-0333-06) | Fresenius Medical Care North America | 2005-12-31 |