FRESENIUS ART HEMOADSORPTION SYSTEM— 510(k) K050273
Substantially EquivalentFresenius Medical Care North America
FDA 510(k) clearance K050273 for FRESENIUS ART HEMOADSORPTION SYSTEM, Substantially Equivalent on 2005-06-08. Applicant: Fresenius Medical Care North America.
Clearance details
- Applicant
- Fresenius Medical Care North America
- Product code
- Code LKN
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lexington, MA, US
Adverse events under product code LKN
product code LKN- Death
- 50
- Injury
- 314
- Total
- 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.