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FDA 510(k) Application Details - K221951
Device Classification Name
More FDA Info for this Device
510(K) Number
K221951
Device Name
Branchor Balloon Guide Catheter
Applicant
Asahi Intecc Co., Ltd
3-100 Akatsuki-cho
Seto 489-0071 JP
Other 510(k) Applications for this Company
Contact
Katsuhiko Fujimura
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QJP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/05/2022
Decision Date
10/11/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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