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FDA 510(k) Application Details - K972110
Device Classification Name
More FDA Info for this Device
510(K) Number
K972110
Device Name
Cordis Endeavor Infusion Catheter
Applicant
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES, FL 33014 US
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Contact
ARIEL MACTAVISH
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Regulation Number
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Classification Product Code
QEY
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Date Received
06/05/1997
Decision Date
08/14/1997
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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