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FDA 510(k) Application Details - K222184
Device Classification Name
Introducer, Catheter
More FDA Info for this Device
510(K) Number
K222184
Device Name
Introducer, Catheter
Applicant
Beijing Demax Medical Technology Co., Ltd.
101, Floor 1-3, 13-7A Jingshengnansi Street, Beijing
Economic-Technological Development Area
Beijing 101102 CN
Other 510(k) Applications for this Company
Contact
Anny Zhang
Other 510(k) Applications for this Contact
Regulation Number
870.1340
More FDA Info for this Regulation Number
Classification Product Code
DYB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/22/2022
Decision Date
02/21/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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