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FDA 510(k) Application Details - K213589
Device Classification Name
More FDA Info for this Device
510(K) Number
K213589
Device Name
FUBUKI XF Neurovascular Long Sheath
Applicant
Asahi Intecc Co., Ltd.
3-100 Akatsuki-cho
Seto 489-0071 JP
Other 510(k) Applications for this Company
Contact
Tomoya Eguchi
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QJP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/12/2021
Decision Date
03/24/2022
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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