FDA 510(k) Application Details - K141782

Device Classification Name Wire, Guide, Catheter

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510(K) Number K141782
Device Name Wire, Guide, Catheter
Applicant Abbott Vascular
3200 LAKESIDE DRIVE
SANTA CLARA, CA 92054 US
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Contact VIVEK THAKKAR
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 07/02/2014
Decision Date 08/07/2014
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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