Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)

Echocardiograph

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Ultra Ice Plus 9 Mhz Intracardiac Echo Catheter(edfu), Ultra Ice Plus 9 Mhz Intracardiac Echo Catheter (paper Dfu).

Pre-market Notification Details

Device IDK160173
510k NumberK160173
Device Name:Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
ClassificationEchocardiograph
Applicant Boston Scientific Corporation 47215 Lakeview Boulevard Fremont,  CA  94538
ContactEric Elliott
CorrespondentEric Elliott
Boston Scientific Corporation 47215 Lakeview Boulevard Fremont,  CA  94538
Product CodeDXK  
CFR Regulation Number870.2330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-01-27
Decision Date2016-02-26
Summary:summary

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