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FDA 510(k) Application Details - K110553
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K110553
Device Name
Wire, Guide, Catheter
Applicant
ASAHI INTECC USA, INC.
2500 RED HILL AVENUE
SUITE 210
SANTA ANA, CA 92705 US
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Contact
YOSHI TERAI
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Regulation Number
870.1330
More FDA Info for this Regulation Number
Classification Product Code
DQX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/28/2011
Decision Date
03/18/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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