Medtronic, Ireland - FDA 510(k) Cleared Devices
Recent clearances: NC Euphora Rapid Exchange Balloon Dilatation Catheter, Euphora Rapid Exchange (RX) Balloon Dilatation Catheter, Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medtronic, Ireland Cardiovascular ✕
9 devices
Cleared
Aug 14, 2026
NC Euphora Rapid Exchange Balloon Dilatation Catheter
Cardiovascular
106d
Cleared
Jul 27, 2026
Euphora Rapid Exchange (RX) Balloon Dilatation Catheter
Cardiovascular
60d
Cleared
Jan 17, 2026
Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
Cardiovascular
205d
Cleared
Oct 29, 2025
Telescope Guide Extension Catheter
Cardiovascular
90d
Cleared
Jun 11, 2025
Liberant Thrombectomy System
Cardiovascular
89d
Cleared
Apr 09, 2013
ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE...
Cardiovascular
182d
Cleared
CT
Oct 22, 2010
SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON
Cardiovascular
14d
Cleared
Aug 21, 2006
ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM
Cardiovascular
83d
Cleared
Mar 16, 2006
ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM
Cardiovascular
97d