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FDA 510(k) Application Details - K032587
Device Classification Name
Catheter, Percutaneous
More FDA Info for this Device
510(K) Number
K032587
Device Name
Catheter, Percutaneous
Applicant
EDWARDS LIFESCIENCES, LLC.
ONE EDWARDS WAY
IRVINE, CA 92614 US
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Contact
KEVIN DRISKO
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Regulation Number
870.1250
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Classification Product Code
DQY
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More FDA Info for this Product Code
Date Received
08/22/2003
Decision Date
10/02/2003
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
Y
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