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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. N.
Plymouth,  MN  55442 -2920
Applicant Contact David Worrell
Correspondent
Ev3, Inc.
4600 Nathan Ln. N.
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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