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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Electrode Recording, Or Probe, Electrode Recording
510(k) Number K102588
Device Name ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE
Applicant
Medtronic Ablation Frontiers, LLC
2210 Faraday Ave.
Suit 100
Carlsbad,  CA  92008
Applicant Contact BRENDA CLAY
Correspondent
Medtronic Ablation Frontiers, LLC
2210 Faraday Ave.
Suit 100
Carlsbad,  CA  92008
Correspondent Contact BRENDA CLAY
Regulation Number870.1220
Classification Product Code
DRF  
Date Received09/09/2010
Decision Date 03/18/2011
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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