K251980

Substantially Equivalent

ClaveQS™ Bag

Applicant
Icu Medical, Inc.
Product code
KPE
Advisory panel
General Hospital
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 KPE

product code KPE
Malfunction
1,000
Other
1
Total
1,001

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.