DeviceClearance

K172071

Substantially Equivalent

Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation)

Applicant
Terumo Cardiovascular Systems Corporation
Product code
DTZ
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Elkton, MD, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code DTZ

product code DTZ
Death
182
Injury
422
Malfunction
3,636
Total
4,240

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.