Vena MicroAngioscope

Primary DI: 07540292001239
Brand: Vena MicroAngioscope
Company: Vena Medical Holdings Corp.
Model: GI-DSP-001
Device description: The Vena MicroAngioscope is the sterile, single use applied part of the Vena MicroAngioscope System.
Published: 2025-11-17
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
Sterile: true
Single use: true

Product Codes#

Code, Name table
Code	Name
LYK	Angioscope

Code, Device, Specialty table
Code	Device	Specialty	Class
LYK	Angioscope	Gastroenterology, Urology	2

Submission, Supplement table
Submission	Supplement
K251767	000
K253842	000

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K251767	000	Vena MicroAngioscope™ System	Vena Medical Holdings Corp	2025-10-01	LYK
K253842	000	Vena MicroAngioscope™ System	Vena Medical Holdings Corp	2026-01-28	LYK

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
07540292001239	Primary	GS1	0

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifier	GTIN-14 normalized	EAN-13
07540292001239	07540292001239	7540292001239

Term, Definition table
Term	Definition
Flexible video angioscope	An endoscope with a very thin, flexible inserted portion intended for the visual examination and treatment of the lumen and patency of blood vessels (especially to evaluate the patency of veins or arteries). It is inserted into the body through an artificial orifice created by an incision. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end and the images showing on a monitor. It is typically used for visualization of the coronary arteries, an arterial bypass procedure with a saphenous vein, or a valvulotomy. This is a reusable device.

Method table
Method

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
07540292000126	Vena Camera Control Unit	GI-SYS-001		2025-11-17