Fathom-16 Steerable Guidewires

Wire, Guide, Catheter

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Fathom-16 Steerable Guidewires.

Pre-market Notification Details

Device IDK170636
510k NumberK170636
Device Name:Fathom-16 Steerable Guidewires
ClassificationWire, Guide, Catheter
Applicant Boston Scientific Corporation Three Scimed Place Maple Grove,  MN  55311
ContactKeith Neligan
CorrespondentKeith Neligan
Boston Scientific Corporation Three Scimed Place Maple Grove,  MN  55311
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-02
Decision Date2017-03-22
Summary:summary

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