FDA.reportPublic FDA data

Venclose, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30118790483011879048Venclose, Inc.1N2026-01-012570 N 1st St Fl 2 # 221 San Jose CA US 95131

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1860391501888525K252316Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)GEI2025-08-19
1860391632178686K250068Venclose digiRF Generator (VCRFG1)GEI2025-02-04
1860391323525118K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven CatheterGEI2021-08-03
1860391029784002K160754Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)GEI2016-09-09
1860391926541990

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI42025-08-19

PMN#

GUDID#