Direxion Torqueable Microcatheter

Catheter, Continuous Flush

BOSTON SCIENTIFIC CORP.

The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Direxion Torqueable Microcatheter.

Pre-market Notification Details

Device IDK142259
510k NumberK142259
Device Name:Direxion Torqueable Microcatheter
ClassificationCatheter, Continuous Flush
Applicant BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE Maple Grove,  MN  55311
ContactMark Lanz
CorrespondentMark Lanz
BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE Maple Grove,  MN  55311
Product CodeKRA  
CFR Regulation Number870.1210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-14
Decision Date2014-09-10
Summary:summary

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