Vena Camera Control Unit

Primary DI
07540292000126
Brand
Vena Camera Control Unit
Company
Vena Medical Holdings Corp.
Model
GI-SYS-001
Device description
The Vena Camera Control Unit (CCU) is the compact, reusable imaging processor 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

Product Codes#

Code, Name table
CodeName
LYKAngioscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYKAngioscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251767000
K253842000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251767000Vena MicroAngioscopeâ„¢ SystemVena Medical Holdings Corp2025-10-01LYK
K253842000Vena MicroAngioscopeâ„¢ SystemVena Medical Holdings Corp2026-01-28LYK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540292000126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540292000126075402920001267540292000126

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video angioscopeAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
203888110
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540292001239Vena MicroAngioscopeGI-DSP-0012025-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540292001239Vena MicroAngioscopeVena Medical Holdings Corp.LYK2025-11-17