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FDA 510(k) Application Details - K230303
Device Classification Name
System, X-Ray, Angiographic
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510(K) Number
K230303
Device Name
System, X-Ray, Angiographic
Applicant
ArteryFlow Technology Co., Ltd.
459 Qianmo Road, Suite C1-501, Binjiang District
Hangzhou 310051 CN
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Contact
Jianping Xiang
Other 510(k) Applications for this Contact
Regulation Number
892.1600
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Classification Product Code
IZI
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More FDA Info for this Product Code
Date Received
02/03/2023
Decision Date
03/02/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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