CARTO 3 EP Navigation System Version 7.2

Computer, Diagnostic, Programmable

Biosense Webster, Inc.

The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Carto 3 Ep Navigation System Version 7.2.

Pre-market Notification Details

Device IDK213264
510k NumberK213264
Device Name:CARTO 3 EP Navigation System Version 7.2
ClassificationComputer, Diagnostic, Programmable
Applicant Biosense Webster, Inc. 31 Technology Drive, Suite 200 Irvine,  CA  92618
ContactKhaled Hamad
CorrespondentKhaled Hamad
Biosense Webster, Inc. 31 Technology Drive, Suite 200 Irvine,  CA  92618
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-30
Decision Date2021-10-29

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