Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface
FDA 510(k) clearance K142784 · decided 2014-10-24
Clearance details
- K-number
- K142784
- Device name
- Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-09-26
- Decision date
- 2014-10-24
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- DTZ
- Device class
- 2
- Regulation number
- 870.4350
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mounds View, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Ve recall (Z-0826-2017) | Medtronic Inc | 2016-12-20 |
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