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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 K143480
Device Name Euphora Rapid Exchange Balloon Dilatation Catheter
Applicant
Medtronic, Inc.
Parkmore Business Park W.
Galway,  IE
Applicant Contact John Kilmartin
Correspondent
Medtronic, Inc.
Parkmore Business Park W.
Galway,  IE
Correspondent Contact Elaine Gullane
Regulation Number870.5100
Classification Product Code
LOX  
Date Received12/08/2014
Decision Date 04/02/2015
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
Recalls CDRH Recalls
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