FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N— 510(k) K070222
Substantially EquivalentFresenius Medical Care North America
FDA 510(k) clearance K070222 for FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N, Substantially Equivalent on 2007-04-24. Applicant: Fresenius Medical Care North America.
Clearance details
- Applicant
- Fresenius Medical Care North America
- 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.