Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir
FDA 510(k) clearance K151791 · decided 2015-11-19
Clearance details
- K-number
- K151791
- Device name
- Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir
- Applicant
- Terumo Cardiovascular Systems Corporation
- Decision
- Substantially Equivalent
- Date received
- 2015-07-01
- Decision date
- 2015-11-19
- Days to decision
- 141 days
- Clearance type
- Special
- Product code
- DTZ
- Device class
- 2
- Regulation number
- 870.4350
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Elkton, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC recall (Z-1347-2023) | Terumo Cardiovascular Systems Corporation | 2023-04-05 |