510(k) K103090 ยท LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
SPECTRA OPTIA R APHERESIS SYSTEM
| Applicant | Caridianbct, Inc.., Lakewood CO, US |
| Decision | Substantially Equivalent, Nov 19, 2010 |
| Received | Oct 19, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103090
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 30, 2012 | CaridianBCT, Inc. Terumo BCT Lakewood, CO 80215, Catalog No 61000 Spectra Optia Apheresis System, Country of Origin: US.
Product Usage:
For use in humans. Within the US marketplace, this device is approved for use in Terminated |
LKN | None listed |
| May 9, 2012 | CaridianBCT, Inc. Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000. Terminated |
LKN | None listed |
| Nov 16, 2011 | Caridian BCT, Incorporated Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215.
A blood component separator used for therapeutic plasma exchanges. Terminated |
LKN | None listed |
| Jun 28, 2011 | Caridian BCT, Incorporated Spectra Optia Apheresis System, REF: 61000, CaridianBCT, Lakewood, CO 80215.
The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic apheresis applications Terminated |
LKN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.