FDA 510(k) Application Details - K024021

Device Classification Name Wire, Guide, Catheter

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510(K) Number K024021
Device Name Wire, Guide, Catheter
Applicant EV3 CORPORATION
4600 NATHAN LN.
PLYMOUTH, MN 55442-2920 US
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Contact PHIL NEURURER
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 12/05/2002
Decision Date 01/24/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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