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FDA 510(k) Application Details - K192782
Device Classification Name
Catheter, Percutaneous
More FDA Info for this Device
510(K) Number
K192782
Device Name
Catheter, Percutaneous
Applicant
Asahi Intecc Co., Ltd.
3-100 Akatsuki-cho
Seto 489-0071 JP
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Contact
Yasuyuki Kawuhara
Other 510(k) Applications for this Contact
Regulation Number
870.1250
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Classification Product Code
DQY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/30/2019
Decision Date
11/29/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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