FDA 510(k) Application Details - K990805

Device Classification Name

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510(K) Number K990805
Device Name MODIFICATION TO 7F HYDROLYSER THROMBECTOMY 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 QEZ
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Date Received 03/11/1999
Decision Date 03/15/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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