FRESENIUS HEMOFLOW F3, F4, F5, F7
FDA 510(k) clearance K874872 · decided 1988-02-19
Clearance details
- K-number
- K874872
- Device name
- FRESENIUS HEMOFLOW F3, F4, F5, F7
- Applicant
- Seratronics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-11-27
- Decision date
- 1988-02-19
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- FJI
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Concord, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemod recall (Z-1324-2016) | Fresenius Medical Care Renal Therapies Group, LLC | 2016-04-05 |