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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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More FDA Info for this Product Code
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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