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FDA 510(k) Application Details - K112452
Device Classification Name
Catheter, Intravascular, Diagnostic
More FDA Info for this Device
510(K) Number
K112452
Device Name
Catheter, Intravascular, Diagnostic
Applicant
ANGIODYNAMICS, INC.
14 PLAZA DRIVE
LATHAM, NY 12110 US
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Contact
TERI JUCKETT
Other 510(k) Applications for this Contact
Regulation Number
870.1200
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Classification Product Code
DQO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/25/2011
Decision Date
03/30/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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