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Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US)

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K250688
510(k) Type
Traditional
Applicant
Acotec Scientific Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
10/7/2025
Days to Decision
215 days
Submission Type
Summary

Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US)

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K250688
510(k) Type
Traditional
Applicant
Acotec Scientific Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
10/7/2025
Days to Decision
215 days
Submission Type
Summary