K020316

Substantially Equivalent

CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR; MODELS 466-P306AU & 466-P306BU

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

Adverse events under product code DQO

product code DQO
Death
35
Injury
993
Malfunction
1,772
Other
5
Total
2,805

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.