510(k) K062264 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM
| Applicant | Medtronic Vascular, Santa Rosa CA, US |
| Decision | Unknown, Nov 8, 2007 |
| Received | Aug 4, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062264
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 19, 2010 | Medtronic CardioVascular Complete SE Biliary Stent System, SC5120L (5 mm x 12 mm), lot number 0000983799, UPC code 00613994186478, use by date 03/17/2011, manufactured by Medtronic CardioVascular, Santa Rosa, CA.
Indicated Terminated |
FGE | None listed |
| Jan 19, 2010 | Medtronic CardioVascular Complete SE Biliary Stent System, SC680L (6 mm x 120 mm), lot number 0000983806, UPC code 006133994186669, use by date 03/17/2011, manufactured by Medtronic CardioVascular, Santa Rosa, CA.
Indicate Terminated |
FGE | None listed |
| Mar 18, 2009 | Medtronic Cardiovascular Medtronic COMPLETE SE Self Expanding Biliary Stent System, Model number SC760L, includes a pre-loaded self-expanding Nickel-Titanium (Nitinol) stent with 8 tantalum radiopaque markers, 4 on each end, Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.