510(k) K093663 ยท KXK Source, Brachytherapy, Radionuclide
RADIONUCLIDE BRACHYTHERAPY SOURCE
| Applicant | C.R. Bard, Inc., Covington GA, US |
| Decision | Substantially Equivalent, Dec 23, 2009 |
| Received | Nov 25, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093663
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 27, 2018 | Bard Brachytherapy, Inc. BARD BrachySource Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). The Terminated |
KXK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.