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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 K090849
Device Name MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150
Applicant
EV3 INC.
9600 54TH AVE NORTH
PLYMOUTH,  MN  55442
Applicant Contact SARA BAKKAR
Correspondent
EV3 INC.
9600 54TH AVE NORTH
PLYMOUTH,  MN  55442
Correspondent Contact SARA BAKKAR
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/30/2009
Decision Date 05/01/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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