Last synced on 25 January 2026 at 3:41 am

Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211806
510(k) Type
Traditional
Applicant
Venclose, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/3/2021
Days to Decision
53 days
Submission Type
Summary

Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211806
510(k) Type
Traditional
Applicant
Venclose, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/3/2021
Days to Decision
53 days
Submission Type
Summary