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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, percutaneous
510(k) Number K183493
Device Name SelectSite C304-HIS Deflectable Catheter System
Medtronic Inc.
Parkmore Business Park West
Galway,  IE
Applicant Contact Sharon Fahy
Medtronic Inc.
Parkmore Business Park West
Galway,  IE
Correspondent Contact Linda O'Connor
Regulation Number870.1250
Classification Product Code
Date Received12/17/2018
Decision Date 03/15/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls