FRESENIUS OPTIFLUX 200A
FDA 510(k) clearance K003498 · decided 2001-01-04
Clearance details
- K-number
- K003498
- Device name
- FRESENIUS OPTIFLUX 200A
- Applicant
- Fresenius Medical Care North America
- Decision
- Substantially Equivalent
- Date received
- 2000-11-13
- Decision date
- 2001-01-04
- Days to decision
- 52 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 F200A High Flux Dialyzers; Product Number: 0500320A. Single Use acute or chronic recall (Z-1104-2014) | Fresenius Medical Care Holdings, Inc. | 2014-02-26 |
| Fresenius Optiflux F160NRe Hemodialyzer Catalog number: 0500316E Intended for patients wit recall (Z-1339-2012) | Fresenius Medical Care Holdings, Inc. | 2012-03-30 |