510(k) Report

Devices descending from K211806

2 later devices reach Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250068Venclose digiRF Generator (VCRFG1)Venclose, Inc.202511
+2K252316Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)Venclose, Inc.20250—