DeviceClearance

K983559

Substantially Equivalent

BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR

Applicant
Icu Medical, Inc.
Product code
FJK
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Clemente, CA, 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.