SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200
FDA 510(k) clearance K071079 · decided 2007-08-02
Clearance details
- K-number
- K071079
- Device name
- SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200
- Applicant
- Gambro Bct, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-04-17
- Decision date
- 2007-08-02
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- LKN
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Lakewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000. recall (Z-1504-2012) | CaridianBCT, Inc. | 2012-05-09 |
| Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. A blood comp recall (Z-0191-2012) | Caridian BCT, Incorporated | 2011-11-16 |
| Spectra Optia Apheresis System, REF: 61000, CaridianBCT, Lakewood, CO 80215. The Spectra O recall (Z-2674-2011) | Caridian BCT, Incorporated | 2011-06-28 |
| Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT La recall (Z-0078-2008) | Gambro BCT, Inc. | 2007-10-31 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COBE CENTRY(R) TPE SYSTEM (P810023/S002) | Gambro Bct, Inc. | 1994-07-05 |
| COBE CENTRY(R) TPE SYSTEM (P810023) | Gambro Bct, Inc. | 1982-03-16 |