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FDA 510(k) Application Details - K983456
Device Classification Name
Catheter,Intracardiac Mapping,High-Density Array
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510(K) Number
K983456
Device Name
Catheter,Intracardiac Mapping,High-Density Array
Applicant
ENDOCARDIAL SOLUTIONS, INC.
1350 ENERGY LN., SUITE 110
ST. PAUL, MN 55108 US
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Contact
ANDREW BALO
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Regulation Number
870.1220
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Classification Product Code
MTD
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More FDA Info for this Product Code
Date Received
09/30/1998
Decision Date
04/21/1999
Decision
SESU - SE - WITH LIMITATIONS
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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