FDA 510(k) Application Details - K123067

Device Classification Name Wire, Guide, Catheter

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510(K) Number K123067
Device Name Wire, Guide, Catheter
Applicant ABBOTT VASCULAR INC.
P.O. BOX 9018
TEMECULA, CA 92591-9018 US
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Contact SEAN MULLIN
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 10/01/2012
Decision Date 01/29/2013
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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