K153213
Substantially EquivalentCapiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir
- Applicant
- Terumo Cardiovascular Systems Corporation
- Product code
- DTZ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Elkton, MD, US
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.