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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intracardiac Mapping, High-Density Array
510(k) Number K123837
Device Name PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
Applicant
BIOSENSE WEBSTER, INC.
3333 DIAMOND CANYON RD.
DIAMOND BAR,  CA  91765
Applicant Contact WAYNE R HOHMAN
Correspondent
BIOSENSE WEBSTER, INC.
3333 DIAMOND CANYON RD.
DIAMOND BAR,  CA  91765
Correspondent Contact WAYNE R HOHMAN
Regulation Number870.1220
Classification Product Code
MTD  
Date Received12/13/2012
Decision Date 03/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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