DeviceClearance

K141834

Substantially Equivalent

SAPPHIRE ADMINISTRATION SET

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

Adverse events under product code FPA

product code FPA
Death
95
Injury
14,421
Malfunction
125,815
Other
30
Total
140,361

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.