ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire

Wire, Guide, Catheter

BOSTON SCIENTIFIC CORPORATION

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Choice Guide Wire, Mailman Guide Wire, Luge Guide Wire, Choice Pt Guide Wire, Pt Graphix Wire.

Pre-market Notification Details

Device IDK143587
510k NumberK143587
Device Name:ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire
ClassificationWire, Guide, Catheter
Applicant BOSTON SCIENTIFIC CORPORATION ONE SCIMED PLACE Maple Grove,  MN  55311 -1566
ContactNikki M Wahlberg
CorrespondentNikki M Wahlberg
BOSTON SCIENTIFIC CORPORATION ONE SCIMED PLACE Maple Grove,  MN  55311 -1566
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-18
Decision Date2015-01-15
Summary:summary

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