SPECTRA OPTIA R APHERESIS SYSTEM
FDA 510(k) clearance K103090 · decided 2010-11-19
Clearance details
- K-number
- K103090
- Device name
- SPECTRA OPTIA R APHERESIS SYSTEM
- Applicant
- Caridianbct, Inc..
- Decision
- Substantially Equivalent
- Date received
- 2010-10-19
- Decision date
- 2010-11-19
- Days to decision
- 31 days
- Clearance type
- Special
- 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 |
|---|---|---|
| Terumo BCT Lakewood, CO 80215, Catalog No 61000 Spectra Optia Apheresis System, Country of recall (Z-1683-2012) | CaridianBCT, Inc. | 2012-05-30 |
| 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 |