Last synced on 14 November 2025 at 11:06 pm

Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)

Page Type
Cleared 510(K)
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)
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