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FDA 510(k) Application Details - K021096
Device Classification Name
Catheter, Peripheral, Atherectomy
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510(K) Number
K021096
Device Name
Catheter, Peripheral, Atherectomy
Applicant
EV3 CORPORATION
4600 NATHAN LN.
PLYMOUTH, MN 55442-2920 US
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Contact
JILL MUNSINGER
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Regulation Number
870.4875
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Classification Product Code
MCW
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More FDA Info for this Product Code
Date Received
04/04/2002
Decision Date
09/08/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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