FDA 510(k) Application Details - K964154

Device Classification Name Catheter, Continuous Flush

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510(K) Number K964154
Device Name Catheter, Continuous Flush
Applicant INTERVENTIONAL INNOVATIONS CORP.
2670 PATTON RD.
ST. PAUL, MN 55113 US
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Contact KAREN E PETERSON, M.S.
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Regulation Number 870.1210

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Classification Product Code KRA
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Date Received 10/16/1996
Decision Date 01/14/1997
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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