FDA 510(k) Application Details - K141831

Device Classification Name Wire, Guide, Catheter

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510(K) Number K141831
Device Name Wire, Guide, Catheter
Applicant BRIVANT LIMITED
PARKMORE WEST BUSINESS PARK
GALWAY IE
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Contact KENNETH WALSH
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 07/07/2014
Decision Date 09/04/2014
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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