FDA 510(k) Application Details - K020890

Device Classification Name Catheter, Intravascular, Diagnostic

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510(K) Number K020890
Device Name Catheter, Intravascular, Diagnostic
Applicant ST. JUDE MEDICAL
14901 DEVEAU PL.
MINNETONKA, MN 55345-2126 US
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Contact KIRK S HONOUR
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Regulation Number 870.1200

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Classification Product Code DQO
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Date Received 03/19/2002
Decision Date 04/17/2002
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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