K163141

Substantially Equivalent

NAMIC ClearaCIL Contrast Injection Lines

Applicant
AngioDynamics, Inc.
Product code
DQO
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Glens Falls, NY, 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.