FDA 510(k) Application Details - K965247

Device Classification Name Catheter, Percutaneous

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510(K) Number K965247
Device Name Catheter, Percutaneous
Applicant CORDIS NEUROVASCULAR, INC.
14740 N.W. 60TH AVE.
MIAMI LAKES, FL 33014 US
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Contact JODI FRASIER
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Regulation Number 870.1250

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Classification Product Code DQY
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Date Received 12/24/1996
Decision Date 07/23/1997
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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