510(k) K071079 ยท LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200
| Applicant | Gambro Bct, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Aug 2, 2007 |
| Received | Apr 17, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071079
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Oct 31, 2007 | Gambro BCT, Inc. Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215. Terminated |
LKN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.