DeviceClearance

K000753

Substantially Equivalent

CORDIS 13F CATHETER SHEATH INTRODUCER

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

Adverse events under product code DRF

product code DRF
Death
127
Injury
1,676
Malfunction
2,003
Other
1
Total
3,807

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.