Company
Medtronic CardioVascular
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 6, 2011 | Medtronic CardioVascular Pioneer Plus Catheter PPlus 120 dual lumen device, inserted through a 6F introducer sheath and placed percutaneously into a peripheral vessel. The device tracks to its intended site in the vasculatur Terminated |
DQY | K081804 |
| Jun 14, 2010 | Medtronic CardioVascular Medtronic Racer Biliary Stent System, Model number XD518YF, UPC code 00721902758164 in a box containing sterilized pouch with product, manufactured by Medtronic Vascular, Sunnyvale, CA.
Medical devic Terminated |
FGE | K032768 |
| 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 | K062264 |
| 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 | K062264 |
| 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 | K062264 |
| Sep 16, 2008 | Medtronic CardioVascular AneuRx AAAdvantage stent graft and the Xcelerant Delivery System with Hydro, Product number ILXCH161685, manufactured by Medtronic Cardiovascular, Santa Rosa, CA. The product is designed to treat inf Terminated |
None listed | |
| Apr 8, 2008 | Medtronic CardioVascular Medtronic brand AneuRx AAAdvantage Endovascular Stent Graft with the Xcelerant Delivery System;
Model Numbers Affected: All AAAdvantage models including:
AEXC202040, IEXC121255, ILXC1212115, I Terminated |
MIH | None listed |