Device Listing 1006957363

Listing Summary#

Listing key: 1006957363
Premarket submission: K242966
Device: Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
Applicant: Gentuity, LLC
Product code: DQO
Decision date: 2025-01-31

Registration key, Registration, FEI table
Registration key	Registration	FEI	Company	Status	Initial importer	Expiration	Address
267098	3011578544	3011578544	GENTUITY, LLC	1	N	2026-01-01	142 North Road Suite G Sudbury MA US 01776