Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir
FDA 510(k) clearance K151389 · decided 2015-10-20
Clearance details
- K-number
- K151389
- Device name
- Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir
- Applicant
- Terumo Cardiovascular Systems Corporation
- Decision
- Substantially Equivalent
- Date received
- 2015-05-26
- Decision date
- 2015-10-20
- Days to decision
- 147 days
- Clearance type
- Traditional
- 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
No recalls on record reference this clearance.