FDA.reportPublic FDA data

CULTIV8 1, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
CULTIV8 1, LLC5N2026-01-013405 Annapolis Ln N Ste 200 Minneapolis MN US 55447

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3511621243706671K253652Genie MAX Large Bore Introducer SheathDYB2026-01-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DYB12026-01-22

GUDID#