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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name introducer, catheter
510(k) Number K110051
Device Name RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT
Applicant
Greatbatch Medical
2300 BERKSHIRE LANE NORTH
MINNEAPOLIS,  MN  55441
Applicant Contact SARA BAKKER
Correspondent
Greatbatch Medical
2300 BERKSHIRE LANE NORTH
MINNEAPOLIS,  MN  55441
Correspondent Contact SARA BAKKER
Regulation Number870.1340
Classification Product Code
DYB  
Date Received01/07/2011
Decision Date 02/02/2012
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
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