510(k) K043246 ยท KXK Source, Brachytherapy, Radionuclide
BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS
| Applicant | C.R. Bard, Inc., Covington GA, US |
| Decision | Substantially Equivalent, Feb 2, 2005 |
| Received | Nov 23, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043246
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 9, 2016 | C.R. Bard, Inc. I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive Seeds in QuickLink Cartridges
Indicated for permanent interstitial treatment of selected localized tumors such as: head an Terminated |
KXK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.