FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS— 510(k) K002761
Substantially EquivalentFresenius Medical Care North America
FDA 510(k) clearance K002761 for FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS, Substantially Equivalent on 2000-12-04. Applicant: Fresenius Medical Care North America. Device class: 2.
Clearance details
- Applicant
- Fresenius Medical Care North America
- Product code
- Code FJI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lexington, MA, US
Recent devices under product code FJI
view allMore clearances from Fresenius Medical Care North America
view allAdverse events under product code FJI
product code FJI- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K002761
K-number listed on FDA's recall record- Z-1098-2014 — Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.
- Z-1102-2014 — Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use acute or chronic hemanalysis treatment.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K002761.
Data sourced from openFDA. This site is unofficial and independent of the FDA.