FDA 510(k) Application Details - K023351

Device Classification Name Catheter, Continuous Flush

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510(K) Number K023351
Device Name Catheter, Continuous Flush
Applicant ADVANCED INTERVENTIONAL TECHNOLOGIES, LLC
100 MAIN ST.
SUITE 120
CONCORD, MA 01742 US
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Contact TRACY PALMER BERNS
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Regulation Number 870.1210

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Classification Product Code KRA
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Date Received 10/07/2002
Decision Date 02/20/2003
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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