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FDA 510(k) Application Details - K012983
Device Classification Name
Catheter, Intravascular, Diagnostic
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510(K) Number
K012983
Device Name
Catheter, Intravascular, Diagnostic
Applicant
ACIST MEDICAL SYSTEMS, INC.
7450 FLYING CLOUDS DR.
SUITE 150
EDEN PRAIRIE, MN 55344 US
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Contact
CARL M BEAURLINE
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Regulation Number
870.1200
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Classification Product Code
DQO
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More FDA Info for this Product Code
Date Received
09/05/2001
Decision Date
03/13/2002
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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