DeviceClearance

K141389

Substantially Equivalent

SAPPHIRE INFUSION PUMP

Applicant
Q Core Medical , Ltd.
Product code
FRN
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Gaithersburg, MD, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FRN

product code FRN
Death
540
Injury
6,178
Malfunction
1,464,165
Other
52
Total
1,470,935

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.