Lightbox L3 L300

GUDID 00851354004509

The Lightbox 3 imaging console is a line-extension of the Lightbox imaging consoles that have been used with catheters in the device families of the Ocelot CTO-crossing catheter system and the Pantheris atherectomy catheter system. The Lightbox 3 console is intended to be used in conjunction with compatible Avinger catheter products by means of an accessory Sled interface to facilitate spinning of fibers at the distal ends of catheters. The Lightbox 3 console houses a laser light source and transmits light to the intraluminal environment through an optical fiber in compatible Avinger products. The Lightbox 3 console receives and interprets the reflected light using a computer to analyze the reflected signal that is returned and processes it in order to present an OCT image of the vessel on the operator monitor in real time.

AVINGER, INC.

Mechanical atherectomy system catheter, peripheral
Primary Device ID00851354004509
NIH Device Record Key842dfc91-9e88-45cf-9a34-b06630e8c0ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameLightbox L3
Version Model NumberL300
Catalog NumberL300
Company DUNS003152968
Company NameAVINGER, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100851354004509 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NQQSystem, Imaging, Optical Coherence Tomography (Oct)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-06
Device Publish Date2024-01-29

Devices Manufactured by AVINGER, INC.

00851354004509 - Lightbox L32024-02-06The Lightbox 3 imaging console is a line-extension of the Lightbox imaging consoles that have been used with catheters in the device families of the Ocelot CTO-crossing catheter system and the Pantheris atherectomy catheter system. The Lightbox 3 console is intended to be used in conjunction with compatible Avinger catheter products by means of an accessory Sled interface to facilitate spinning of fibers at the distal ends of catheters. The Lightbox 3 console houses a laser light source and transmits light to the intraluminal environment through an optical fiber in compatible Avinger products. The Lightbox 3 console receives and interprets the reflected light using a computer to analyze the reflected signal that is returned and processes it in order to present an OCT image of the vessel on the operator monitor in real time.
00851354004509 - Lightbox L32024-02-06 The Lightbox 3 imaging console is a line-extension of the Lightbox imaging consoles that have been used with catheters in the de
00851354004578 - Pantheris LV2024-02-06 The Pantheris LV Catheter is a monorail (rapid exchange) device with an effective length of 110 cm, compatible with standard 7F
00851354004554 - Tigereye ST2023-08-01 The Tigereye ST System is intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions
00851354004493 - Tigereye2023-03-22 The Tigereye System is intended to facilitate the intraluminal placement conventional guide wires beyond stenotic lesions (inclu
00851354004417 - Pantheris SV2019-08-12 The Pantheris SV System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature
00851354004004 - Wildcat2019-03-29 "The Wildcat CTO Catheter is intended to create a channel in totally occluded peripheral vessels. The device may also be used to
00851354004028 - Wildcat2019-03-29 "The Wildcat CTO Catheter is intended to create a channel in totally occluded peripheral vessels. The device may also be used to
00851354004042 - Kittykat II2019-03-29 "Kittycat 2 Catheter is a 5F sheath and 0.014” guidewire compatible over-the-wire device with a working length of 150 cm. It

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.