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Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K160754
510(k) Type
Traditional
Applicant
VENCLOSE, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/9/2016
Days to Decision
175 days
Submission Type
Summary

Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K160754
510(k) Type
Traditional
Applicant
VENCLOSE, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/9/2016
Days to Decision
175 days
Submission Type
Summary