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FDA 510(k) Application Details - K161362
Device Classification Name
Catheter, Percutaneous
More FDA Info for this Device
510(K) Number
K161362
Device Name
Catheter, Percutaneous
Applicant
Asahi Intecc Co., Ltd.
1703 Wakita-cho, Moriyama-Ku
Nagoya 463-0024 JP
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Contact
Carroll Councilman
Other 510(k) Applications for this Contact
Regulation Number
870.1250
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Classification Product Code
DQY
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More FDA Info for this Product Code
Date Received
05/16/2016
Decision Date
06/14/2016
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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