K870067

Substantially Equivalent

MULTICATH - CODE#S 8.1207.OO/8.1208.00/8.1205.20

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

Adverse events under product code DQY

product code DQY
Death
464
Injury
4,489
Malfunction
13,721
Other
2
Total
18,676

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.