DeviceClearance

K113773

Substantially Equivalent

ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL

Applicant
St Jude Medical
Product code
KRA
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sylmar, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code KRA

product code KRA
Death
234
Injury
1,029
Malfunction
3,012
Other
2
Total
4,277

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.