K851420

Substantially Equivalent

MULTICOR S, MODELS 330A/331A

Applicant
Cordis Corp.
Product code
DXY
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Miami, FL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code DXY

product code DXY
Death
240
Injury
2,328
Malfunction
2,096
Total
4,664

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.