DeviceClearance

K953254

Unknown

STRATO/INFUSAID INFUSE-A-KIT

Applicant
Strato/Infusaid, Inc.
Product code
LJT
Advisory panel
General Hospital
Date received
Decision date
Decision
Unknown
Clearance type
Traditional
Location
Norwood, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code LJT

product code LJT
Death
234
Injury
6,468
Malfunction
5,326
Other
2
Total
12,030

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.