FDA 510(k) Applications Submitted by Crystal Lee

FDA 510(k) Number Submission Date Device Name Applicant
K230705 03/14/2023 POT PTCA Balloon Dilatation Catheter BrosMed Medical Co., Ltd.
K241478 05/24/2024 Tri-Wedge PTA Scoring Balloon Dilatation Catheter BrosMed Medical Co., Ltd.
K212215 07/15/2021 Tiche PTA Balloon Dilatation Catheter BrosMed Medical Co., Ltd.
K243704 11/29/2024 Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter BrosMed Medical Co., Ltd.


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