LumenCross Imaging Catheter

Basic Information

• Brand Name: LumenCross Imaging Catheter
• Primary DI: 06971141530517
• Version / Model: F2
• Company Name: Shenzhen Vivolight Medical Device & Technology Co., Ltd.
• Labeler DUNS: 543028475
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-28
• Public Version: 1
• Public Version Date: 2025-10-06
• Public Version Status: New
• Public Device Record Key: 9b83b205-daa5-40a0-85d3-4f58aedaa4cd

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	870.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47491	Coronary optical coherence tomography system catheter	A sterile flexible tube with an extremely fine working end that houses an optical fibre and imaging lens intended to be transcutaneously introduced into the coronary vasculature to perform coronary optical coherence tomography (OCT). The proximal end of the device connects to a coronary OCT console for the transmission of high-resolution images (e.g., 5 to 40 micron) of the coronary intravasculature. It is typically made of stainless steel, plastic, and optical materials. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06971141530517	GS1

Premarket Submissions

Submission Number	Supplement Number
K242098	000