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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 K092299
Device Name TRAILBLAZER SUPPORT CATHETER
Applicant
EV3 INC
1394 25TH STREET NW
BUFFALO,  MN  55113 -2920
Applicant Contact DAVID ROBERTSON
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Regulation Number870.1250
Classification Product Code
DQY  
Date Received07/29/2009
Decision Date 08/07/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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