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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 K082854
Device Name NANOCORSS .014 OTW PTA DILATATION CATHETER
Applicant
EV3 INC.
4600 NATHAN LN. NORTH
PLYMOUTH,  MN  55442 -2920
Applicant Contact David Worrell
Correspondent
EV3 INC.
4600 NATHAN LN. NORTH
PLYMOUTH,  MN  55442 -2920
Correspondent Contact David Worrell
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/29/2008
Decision Date 12/04/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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