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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, percutaneous
510(k) Number K162384
Device Name TrailBlazer Angled Support Catheter
Applicant
Medtronic Vascular, Inc.(formerly ev3 Inc.)
3033 Campus Dr
plymouth,  MN  55441
Applicant Contact david robertson
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
saint paul,  MN  55114
Correspondent Contact mark job
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/25/2016
Decision Date 09/22/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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