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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 K063210
Device Name ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488
Applicant
MEDTRONIC INC., CARDIAC RHYTHM MANAGEMENT
1015 GRAMSIE RD
SHOREVIEW,  MN  55126 -3082
Applicant Contact MICHELLE NIVALA
Correspondent
MEDTRONIC INC., CARDIAC RHYTHM MANAGEMENT
1015 GRAMSIE RD
SHOREVIEW,  MN  55126 -3082
Correspondent Contact MICHELLE NIVALA
Regulation Number870.1330
Classification Product Code
DQX  
Date Received10/23/2006
Decision Date 03/15/2007
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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