FDA 510(k) Applications Submitted by Jenny Zhu

FDA 510(k) Number Submission Date Device Name Applicant
K220036 01/05/2022 Wellead Ureteral Catheter Well Lead Medical Co., Ltd.
K220722 03/14/2022 PVC Hydrophilic Urethral Catheter Well Lead Medical Co., Ltd.
K241734 06/17/2024 Wellead« Hydrophilic Intermittent Catheter Ready to Use; Wellead« Hydrophilic Intermittent Catheter Compact Well Lead Medical Co., Ltd.
K202134 07/31/2020 Well Lead All Silicone Foley Catheter with Temperature Sensor Well Lead Medical Co., LTD.
K233094 09/26/2023 Wellead« Latex Foley Catheter Well Lead Medical (Hainan) Co., Ltd.
K203119 10/16/2020 ClearPetra Suction-Evacuation Sheath Well Lead Medical Co., LTD.


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