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FDA 510(k) Application Details - K223189
Device Classification Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
More FDA Info for this Device
510(K) Number
K223189
Device Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant
Shanghai MicroPort Medical (Group) Co., Ltd.
1601 ZhangDong Road, ZJ Hi-Tech Park
Shanghai 201203 CN
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Contact
Xia Tian
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LOX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/12/2022
Decision Date
07/21/2023
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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