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FDA 510(k) Application Details - K043538
Device Classification Name
Catheter, Continuous Flush
More FDA Info for this Device
510(K) Number
K043538
Device Name
Catheter, Continuous Flush
Applicant
CORDIS NEUROVASCULAR, INC.
14000 N.W. 57TH CT.
MIAMI LAKES, FL 33014 US
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Contact
MARITZA CELAYA
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Regulation Number
870.1210
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Classification Product Code
KRA
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More FDA Info for this Product Code
Date Received
12/22/2004
Decision Date
04/18/2005
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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