Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir— 510(k) K151389
Substantially EquivalentTerumo Cardiovascular Systems Corporation
FDA 510(k) clearance K151389 for Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir, Substantially Equivalent on 2015-10-20. Applicant: Terumo Cardiovascular Systems Corporation.
Clearance details
- Applicant
- Terumo Cardiovascular Systems Corporation
- Product code
- Code DTZ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- 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.