Optiflux Enexa F500 Dialyzer— 510(k) K192928
Substantially EquivalentFresenius Medical Care Reanal Therapies Group, LLC
FDA 510(k) clearance K192928 for Optiflux Enexa F500 Dialyzer, Substantially Equivalent on 2020-07-09. Applicant: Fresenius Medical Care Reanal Therapies Group, LLC.
Clearance details
- Applicant
- Fresenius Medical Care Reanal Therapies Group, LLC
- Product code
- Code KDI
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
Adverse events under product code KDI
product code KDI- Death
- 352
- Injury
- 1,474
- Malfunction
- 12,534
- Other
- 4
- Total
- 14,364
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.