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
20643169694945 K162384 000
20763000004815 K162384 000
20763000004822 K162384 000
20763000004839 K162384 000
20763000004846 K162384 000
20763000004853 K162384 000
20763000004860 K162384 000
20763000004877 K162384 000
20763000004884 K162384 000
20763000004808 K162384 000
20763000770383 K162384 000
20763000770307 K162384 000
20763000770314 K162384 000
20763000770321 K162384 000
20763000770338 K162384 000
20763000770345 K162384 000
20763000770352 K162384 000
20763000770369 K162384 000
20763000770376 K162384 000
20763000004891 K162384 000
20763000104645 K162384 000
20643169694860 K162384 000
20643169694877 K162384 000
20643169694884 K162384 000
20643169694891 K162384 000
20643169694907 K162384 000
20643169694914 K162384 000
20643169694921 K162384 000
20643169694938 K162384 000
20643169694853 K162384 000
20763000104737 K162384 000
20763000104652 K162384 000
20763000104669 K162384 000
20763000104676 K162384 000
20763000104683 K162384 000
20763000104690 K162384 000
20763000104706 K162384 000
20763000104713 K162384 000
20763000104720 K162384 000
20763000770291 K162384 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.