DeviceClearance

K001107

Substantially Equivalent

FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)

Applicant
Fresenius Medical Care North America
Product code
FJK
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lexington, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FJK

product code FJK
Death
52
Malfunction
3,430
Total
3,482

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.