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FDA 510(k) Application Details - K211438
Device Classification Name
Catheter,Intracardiac Mapping,High-Density Array
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510(K) Number
K211438
Device Name
Catheter,Intracardiac Mapping,High-Density Array
Applicant
Biosense Webster, Inc.
31 Technology Drive Suite 200
Irvine, CA 92618 US
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Contact
John Jimenez
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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
05/10/2021
Decision Date
03/18/2022
Decision
SESE - SUBST EQUIV
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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