FDA 510(k) Application Details - K972110

Device Classification Name

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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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