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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peripheral, Atherectomy
510(k) Number K021096
Device Name X-SIZER CATHETER SYSTEM
Applicant
Ev3 Corporation
4600 Nathan Ln.
Plymouth,  MN  55442 -2920
Applicant Contact JILL MUNSINGER
Correspondent
Ev3 Corporation
4600 Nathan Ln.
Plymouth,  MN  55442 -2920
Correspondent Contact JILL MUNSINGER
Regulation Number870.4875
Classification Product Code
MCW  
Date Received04/04/2002
Decision Date 09/08/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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