CARTO 3 EP Navigation System, Version 5.2 And Accessories With CARTOFINDER Module

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 5.2 And Accessories With Cartofinder Module.

Pre-market Notification Details

Device IDK173978
510k NumberK173978
Device Name:CARTO 3 EP Navigation System, Version 5.2 And Accessories With CARTOFINDER Module
ClassificationComputer, Diagnostic, Programmable
Applicant Biosense Webster, Inc. 33 Technology Drive Irvine,  CA  92618
ContactPhuong Chau
CorrespondentPhuong Chau
Biosense Webster, Inc. 33 Technology Drive Irvine,  CA  92618
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-29
Decision Date2018-08-24

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