FDA.reportPublic FDA data

KARDIUM Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30076038553007603855KARDIUM Inc.1N2026-01-018518 Glenlyon Parkway, Unit 155 Burnaby British Columbia CA V5J0B6

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
991211252380028P240044Globe® Pulsed Field SystemQZI2025-08-27
991211104342397K250747Globe® Pulsed Field SystemDQK2025-06-25
991211567579040K250529Globe Introducer (601-01001)DRA2025-06-03
991211490220955
991211523420139
991211720786068
991211990096506

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQK12025-06-25
DRA12025-06-03

PMN#

GUDID#