AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE
FDA 510(k) clearance K973760 · decided 1998-02-18
Clearance details
- K-number
- K973760
- Device name
- AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE
- Applicant
- Avecor Cardiovascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-10-02
- Decision date
- 1998-02-18
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- DTZ
- Device class
- 2
- Regulation number
- 870.4350
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic Trillium Affinity NT, 541T, Integrated CVR/Membrane Oxygenator (Plasma Resistant recall (Z-0476-2008) | Medtronic Perfusion Systems | 2008-01-26 |
| Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous R recall (Z-0815-04) | Medtronic Perfusion Systems | 2004-07-20 |