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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 K261428
Device Name NC Euphora Rapid Exchange Balloon Dilatation Catheter
Applicant
Medtronic Ireland
Parkmore Business Park W.
Galway , Ireland
Galway,  IE H91 VY19
Applicant Contact Michelle Greaney
Correspondent
Medtronic Ireland
Parkmore Business Park W.
Galway , Ireland
Galway,  IE H91 VY19
Correspondent Contact Michelle Greaney
Regulation Number870.5100
Classification Product Code
LOX  
Date Received04/30/2026
Decision Date 08/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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