DeviceClearance

K760013

Substantially Equivalent

PACER SYSTEMS ANALYZER (CORDIS)

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

Adverse events under product code DTC

product code DTC
Injury
136
Malfunction
3,400
Total
3,536

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.