FDA 510(k) Applications Submitted by Goodman Co., Ltd.

FDA 510(k) Number Submission Date Device Name Applicant
K232013 07/06/2023 Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14 Goodman Co., Ltd.
K243944 12/20/2024 Aperta NSE PTA Balloon Dilatation Catheter Goodman Co., Ltd.


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