FDA 510(k) Application Details - K852123

Device Classification Name Wire, Guide, Catheter

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510(K) Number K852123
Device Name Wire, Guide, Catheter
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC.
1395 CHARLESTON RD.
MOUNTAIN VIEW, CA US
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Contact JANE E BEGGS
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 05/15/1985
Decision Date 06/19/1985
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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