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FDA 510(k) Application Details - K213065
Device Classification Name
More FDA Info for this Device
510(K) Number
K213065
Device Name
Distal Access Catheter
Applicant
Guangzhou Easycess Medical Co., Ltd
Room 701, Building B4, 11 Kaiyuan Avenue, Huangpu District
Guangzhou 510530 CN
Other 510(k) Applications for this Company
Contact
Xingcheng Liu
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QJP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/23/2021
Decision Date
05/31/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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