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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name wire, guide, catheter
510(k) Number K120863
Device Name WHOLEY GUIDE WIRE SYSTEM
Original Applicant
Covidien LLC
3033 campus drive
plymouth,  MN  55441
Original Contact david rbertson
Regulation Number870.1330
Classification Product Code
DQX  
Date Received03/22/2012
Decision Date 04/19/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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