COBE CMS-FS MEMBRANE OXYGENATOR
FDA 510(k) clearance K926467 · decided 1993-11-09
Clearance details
- K-number
- K926467
- Device name
- COBE CMS-FS MEMBRANE OXYGENATOR
- Applicant
- Cobe Cardiovascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-12-28
- Decision date
- 1993-11-09
- Days to decision
- 316 days
- Clearance type
- Traditional
- Product code
- DTZ
- Device class
- 2
- Regulation number
- 870.4350
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Arvada, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cobe Optima XP Hollow Fiber Membrane Oxygenator/Reservoir, Sterile, (Standalone Systems) C recall (Z-1422-06) | Cobe Cardiovascular, Inc | 2006-08-24 |
| Cobe Optima XP Hollow Fiber Membrane Oxygenator, Sterile, (Custom Heart/Lung Packs), Catal recall (Z-1425-06) | Cobe Cardiovascular, Inc | 2006-08-24 |