510(k) K151791
Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir by
Terumo Cardiovascular Systems Corporation
— Product Code DTZ
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 19, 2015
- Date Received
- July 1, 2015
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oxygenator, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4350
- Review Panel
- CV
- Submission Type