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510(k) K243175

Disposable Intermittent Catheter (TPU Catheter) by Chengdu Daxan Innovative Medical Tech. Co., Ltd. — Product Code EZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2025
Date Received
September 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Straight
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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