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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
Recalls CDRH Recalls
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