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FDA 510(k) Application Details - K141751
Device Classification Name
Guide, Wire, Catheter, Neurovasculature
More FDA Info for this Device
510(K) Number
K141751
Device Name
Guide, Wire, Catheter, Neurovasculature
Applicant
ASAHI INTECC CO., LTD.
5523 RESEARCH PARK DRIVE
SUITE 205
BALTIMORE, MD 21228 US
Other 510(k) Applications for this Company
Contact
SEMIH OKTAY
Other 510(k) Applications for this Contact
Regulation Number
870.1330
More FDA Info for this Regulation Number
Classification Product Code
MOF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/30/2014
Decision Date
01/30/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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