JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire

Wire, Guide, Catheter

Boston Scientific

The following data is part of a premarket notification filed by Boston Scientific with the FDA for Judo 1 Guidewire, Judo 3 Guidewire, Judo 6 Guidewire.

Pre-market Notification Details

Device IDK180795
510k NumberK180795
Device Name:JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire
ClassificationWire, Guide, Catheter
Applicant Boston Scientific Three Scimed Place Maple Grove,  MN  55311 -1566
ContactNikki M. Ibis
CorrespondentNikki M. Ibis
Boston Scientific Three Scimed Place Maple Grove,  MN  55311 -1566
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-27
Decision Date2018-04-12
Summary:summary

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