FRSENIUS PD IQCARD CYCLER— 510(k) K002892
Substantially EquivalentFresenius Medical Care North America
FDA 510(k) clearance K002892 for FRSENIUS PD IQCARD CYCLER, Substantially Equivalent on 2001-04-05. Applicant: Fresenius Medical Care North America.
Clearance details
- Applicant
- Fresenius Medical Care North America
- Product code
- Code FKX
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lexington, MA, US
Adverse events under product code FKX
product code FKX- Death
- 501
- Injury
- 6,720
- Malfunction
- 18,508
- Other
- 1
- Total
- 25,730
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.