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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Transluminal Coronary Angioplasty, Percutaneous
510(k) Number K261759
Device Name Euphora Rapid Exchange (RX) Balloon Dilatation Catheter
Applicant
Medtronic Ireland
Parkmore Business Park W.
Galway,  IE H91 VY19
Applicant Contact Sarah Grant
Correspondent
Medtronic Ireland
Parkmore Business Park W.
Galway,  IE H91 VY19
Correspondent Contact Sarah Grant
Regulation Number870.5100
Classification Product Code
LOX  
Date Received05/28/2026
Decision Date 07/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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