FDA.reportPublic FDA data

Coronary optical coherence tomography system catheter

Definition
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.
GUDID devices
15
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00628055603054Novasight Hybrid™ CatheterConavi Medical IncTA-06-00012020-09-09
06971141530517LumenCross Imaging CatheterShenzhen Vivolight Medical Device & Technology Co., Ltd.F22025-09-28
00859910007148Vis-Rx PrimeGENTUITY LLCG312025-04-09
00628055603115Novasight Hybrid™ CatheterConavi Medical IncTA-06-00012023-04-17
00859910007018Vis-RxGENTUITY LLCUS Catheter Kit G30-012021-02-11
00628055603061Novasight Hybrid™ Catheter Accessories PackageConavi Medical IncSA-10-00222020-09-11
00628055603108Novasight Hybrid™ Catheter PIM BagConavi Medical IncSA-10-00292020-09-11
01628055603053Novasight Hybrid™ CatheterConavi Medical IncTA-06-00012020-09-09
05415067031129Dragonfly OpStar™LIGHTLAB IMAGING, INC.10146512019-12-17
00183739000562C7 Dragonfly™LIGHTLAB IMAGING, INC.100-100-002015-04-17
00183739000623Dragonfly™LIGHTLAB IMAGING, INC.Kit2015-04-20
00183739000647Dragonfly™ OPTIS™LIGHTLAB IMAGING, INC.C4086452015-04-20
00183739000654Dragonfly™ OPTIS™LIGHTLAB IMAGING, INC.C4086462015-04-20
00183739000692Dragonfly™LIGHTLAB IMAGING, INC.Duo Kit2015-04-20
00183739000708Dragonfly™LIGHTLAB IMAGING, INC.Duo2015-04-20