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FDA 510(k) Application Details - K212567
Device Classification Name
Catheter, Straight
More FDA Info for this Device
510(K) Number
K212567
Device Name
Catheter, Straight
Applicant
Chengdu Daxan Innovative Medical Tech. Co., Ltd
Unit 6, Building 1, No.18, North Bayi Road,
Wenjiang District
Chengdu 611135 CN
Other 510(k) Applications for this Company
Contact
Kevin Huang
Other 510(k) Applications for this Contact
Regulation Number
876.5130
More FDA Info for this Regulation Number
Classification Product Code
EZD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/16/2021
Decision Date
12/07/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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