AVVIGO Guidance System

Computer, Diagnostic, Programmable

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Avvigo Guidance System.

Pre-market Notification Details

Device IDK201713
510k NumberK201713
Device Name:AVVIGO Guidance System
ClassificationComputer, Diagnostic, Programmable
Applicant Boston Scientific Corporation Three Scimed Place Maple Grove,  MN  55311
ContactKevin Catalano
CorrespondentKevin Catalano
Boston Scientific Corporation Three Scimed Place Maple Grove,  MN  55311
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-23
Decision Date2020-07-23

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