TrailBlazer Angled Support Catheter

Catheter, Percutaneous

Medtronic Vascular, Inc.(formerly Ev3 Inc.)

The following data is part of a premarket notification filed by Medtronic Vascular, Inc.(formerly Ev3 Inc.) with the FDA for Trailblazer Angled Support Catheter.

Pre-market Notification Details

Device IDK162384
510k NumberK162384
Device Name:TrailBlazer Angled Support Catheter
ClassificationCatheter, Percutaneous
Applicant Medtronic Vascular, Inc.(formerly Ev3 Inc.) 3033 Campus Dr Plymouth,  MN  55441
ContactDavid Robertson
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2016-08-25
Decision Date2016-09-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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