Device Listing 1243706671

Listing Summary#

Listing key: 1243706671
Premarket submission: K253652
Device: Genie MAX Large Bore Introducer Sheath
Applicant: Cultiv8 1, LLC
Product code: DYB
Decision date: 2026-01-22

Registration key, Company, Status table
Registration key	Company	Status	Initial importer	Expiration	Address
351162	CULTIV8 1, LLC	5	N	2026-01-01	3405 Annapolis Ln N Ste 200 Minneapolis MN US 55447