K060734

Substantially Equivalent

FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE)

Applicant: Fresenius Medical Care North America
Product code: LKN
Advisory panel: Unknown
Date received: 2006-03-20
Decision date: 2006-09-05
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, 2020-01-01 through 2026-04-23. 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.