Company ยท IE
Medtronic, Ireland
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2026. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (3 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 14, 2026 | K261428 | NC Euphora Rapid Exchange Balloon Dilatation Catheter Medtronic Ireland, IE | LOX |
| Jul 27, 2026 | K261759 | Euphora Rapid Exchange (RX) Balloon Dilatation Catheter Medtronic Ireland, IE | LOX |
| Jan 17, 2026 | K251970 | Sprinter Legend Rapid Exchange Balloon Dilatation Catheter Medtronic, Ireland, IE | LOX |
| Oct 29, 2025 | K252390 | Telescope Guide Extension Catheter Medtronic, Ireland, IE | DQY |
| Jun 11, 2025 | K250787 | Liberant Thrombectomy System Medtronic, Ireland, IE | QEW |
| Apr 9, 2013 | K123153 | ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT Medtronic, Ireland, IE | DQY |
| Oct 22, 2010 | K103095 | SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON Medtronic, Ireland | LOX |
| Aug 21, 2006 | K061480 | ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM Medtronic, Ireland | DQY |
| Mar 16, 2006 | K053431 | ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM Medtronic, Ireland | DQY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||