FDA 510(k) Application Details - K914531

Device Classification Name Wire, Guide, Catheter

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510(K) Number K914531
Device Name Wire, Guide, Catheter
Applicant ARROW INTL., INC.
P.O. BOX 6306
HILL AND GEORGE AVENUES
READING, PA US
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Contact THOMAS D NICKEL
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 10/11/1991
Decision Date 02/27/1992
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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