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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 K251970
Device Name Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
Applicant
Medtronic, Ireland
Parkmore Business Park W.
Galway,  IE H91VY19
Applicant Contact Michelle Greaney
Correspondent
Medtronic, Ireland
Parkmore Business Park W.
Galway,  IE H91VY19
Correspondent Contact Michelle Greaney
Regulation Number870.5100
Classification Product Code
LOX  
Date Received06/26/2025
Decision Date 01/17/2026
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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