AVINGER, INC.

FDA Registration(s)#

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

• avinger.com

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• Pantheris LV Atherectomy Catheter

  2023-06-06

  Avinger, Inc.

• Tigereye ST CTO-Crossing Catheter

  2023-04-25

  Avinger, Inc.

• Tigereye CTO-Crossing Catheter

  2022-01-06

  Avinger, Inc.

• Pantheris System

  2021-11-16

  Avinger, Inc.

• Tigereye CTO-Crossing Catheter

  2020-09-10

  Avinger, Inc.

• Pantheris SV

  2019-04-09

  Avinger, Inc.

• Pantheris System

  2018-05-22

  Avinger, Inc.

• Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled

  2017-10-30

  Avinger, Inc.

• Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled

  2016-12-21

  Avinger, Inc.

• Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled

  2016-10-18

  Avinger, Inc

• Pantheris Catheter

  2016-04-21

  AVINGER, INC.

• Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)

  2016-03-01

  AVINGER, INC.

• Pantheris System

  2015-10-14

  Avinger, Inc.

• OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE

  2014-05-01

  AVINGER, INC.

• OCELOT PIXL CATHETER

  2012-12-14

  AVINGER, INC.

• OCELOT CATHETER

  2012-12-07

  AVINGER, INC.

• OCELOT SYSTEM

  2012-11-07

  AVINGER, INC.

• KITTYCAT CATHETER, KITTYCAT 2 CATHETER

  2012-03-30

  AVINGER, INC.

• WILDCAT CATHETER

  2012-03-12

  AVINGER, INC.

• WILDCAT 5F GUIDEWIRE SUPPORT CATHETER

  2011-10-06

  AVINGER, INC.

• AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX

  2011-09-09

  AVINGER, INC.

• WILDCAT CATHETER

  2011-08-11

  AVINGER, INC.

• WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500

  2010-08-06

  AVINGER, INC.

• WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S

  2010-08-06

  AVINGER, INC.

• WILDCAT 7F GUIDEWIRE SUPPORT CATHETER

  2009-02-02

  AVINGER, INC.

GUDID#

• Pantheris - The Pantheris System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 3.0 mm to 7.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies.

  AVINGER, INC.

  2019-03-21

• Pantheris - The Pantheris System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 3.0 mm to 7.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies.

  AVINGER, INC.

  2019-03-21

• CO2 - The CO2 Regulator System is intended to supply low pressure CO2, where small volumes of CO2 are needed, during medical procedures. The device is not intended to be marketed for any specific treatment or medical purpose.The CO2 Cartridge is a component of the Avinger CO2 Regulator System which also includes a CO2 regulator (regulator), male luer lock connector and a female-female luer lock connector (removable). The Avinger CO2 Regulator System allows for the CO2 cartridge to be replaced once the gas from the engaged CO2 cartridge has been spent. Replacement CO2 Cartridges are shipped in packs of five (5).

  AVINGER, INC.

  2019-03-21

• Ocelot IV - The Ocelot System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures. The Ocelot System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.

  AVINGER, INC.

  2019-03-21

• Ocelot III - The Ocelot System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures. The Ocelot System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.

  AVINGER, INC.

  2019-03-21

• Pantheris SV - The Pantheris SV System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 2.0 mm to 4.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies.

  AVINGER, INC.

  2019-08-02

• Tigereye - The Tigereye System is intended to facilitate the intraluminal placement conventional guide wires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures.

  AVINGER, INC.

  2023-03-14

• Tigereye ST - The Tigereye ST System is intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures.

  AVINGER, INC.

  2023-07-24

• Pantheris LV - The Pantheris LV Catheter is a monorail (rapid exchange) device with an effective length of 110 cm, compatible with standard 7F sheaths and 0.014” guidewires. It consists of a lubricious coated torque shaft with a proximal handle assembly and an atraumatic distal assembly. The distal assembly of the catheter consists of an imaging assembly, a rotating cutter, an apposition jog, and a flexible, tiltable nosecone with a radiopaque fuel gauge. The distal end of the catheter includes an approximately 13 cm length guidewire lumen, accommodating standard 0.014” guidewires. The nosecone component of the catheter is 6 cm long. The catheter is sterilized by electron beam and is intended for single use only.

  AVINGER, INC.

  2024-01-29

• Lightbox L3 - 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.

  2024-01-29

• Sterile Drape - The Sterile Drape is designed to function as a protective barrier between the sterile and non-sterile environments during surgical procedures

  AVINGER, INC.

  2019-03-21

• Lightbox Umbilical - Lightbox Umbilical is intended for use in peripheral vascular procedures in conjunction with a compatible Avinger product.

  AVINGER, INC.

  2019-03-21

• Ocelot PIXL - """The Ocelot PIXL System consists of the Ocelot PIXL Catheter (“Ocelot PIXL”), the Lightbox console (“Lightbox”), and the Lightbox Umbilical (“Umbilical”). This system combines the use of Avinger’s peripheral catheter designs and an Optical Coherence Tomography (OCT) intravascular orientation and imaging tool. The Ocelot PIXL System is intended to cross chronic total occlusions in the peripheral vasculature while simultaneously providing OCT visualization to help orient the distal tip of the Ocelot PIXL to support the primary intended use. Use of Ocelot PIXL in conjunction with Lightbox allows for OCT imaging as an adjunct to fluoroscopy which facilitates intravascular orientation of the catheter. See Lightbox Operator’s Manual and Umbilical IFU for guidance on setting up and using the Lightbox and Umbilical, respectively. Ocelot PIXL is available in 2 different lengths, 135cm working length and 150cm working length.Ocelot PIXL is an over-the-wire device compatible with a 5F sheath and 0.014” guidewire. It consists of a catheter shaft with handle assembly at the proximal end and a distal tip designed to cross CTOs. A locking luer connecter at the proximal end provides entry to a lumen that supports and facilitates movement of a guidewire (i.e., Lumen Flush Port). The catheter is sterilized by ethylene oxide and is intended for single use only. """

  AVINGER, INC.

  2019-03-21

• Lightbox Umbilical - Lightbox Umbilical is intended for use in peripheral vascular procedures in conjunction with a compatible Avinger product.

  AVINGER, INC.

  2019-03-21

• Juicebox - Juicebox is an optional accessory to facilitate catheter tip rotation when using a compatible Avinger catheter. It consists of a handle with a Rotation Toggle Switch and a Release Button. Juicebox is designed to be placed over the catheter handle. This accessory is irradiated for sterility and is intended for single use only. When Juicebox is properly placed over a catheter handle, it locks into place. Depressing the Rotation Toggle Switch activates the power for rotation in either the clockwise or counterclockwise directions. The Release Button releases Juicebox so that it can be removed from the catheter handle.The Juicebox is an optional accessory that may be used to facilitate catheter tip rotation when using a compatible Avinger catheter.

  AVINGER, INC.

  2019-03-21

• Kittykat II - """Kittycat 2 Catheter is a 5F sheath and 0.014” guidewire compatible over-the-wire device with a working length of 150 cm. It consists of a catheter shaft with handle assembly at the proximal end and an atraumatic Distal Tip. A locking Luer connecter at the proximal end provides entry to a lumen that supports and facilitates movement of a guidewire. The catheter has been irradiated for sterility and is intended for single use only.The Distal Tip houses Spiral Flutes and allows atraumatic advancement of the catheter through the vasculature. The pre-shaped Distal Tip is made of a malleable material and may be reshaped as needed by the user. The deflection of the Distal Tip is visible under fluoroscopic guidance.The handle assembly consists of a Handle Body, Rotator, and Luer. The Handle Body controls rotational orientation of the catheter, including the flexible Distal Tip. The Rotator controls the rotational movement of the Distal Tip, independent of the catheter orientation. The Luer is provided at the proximal end to facilitate fluid flush and the entry/exit of the guidewire. Kittycat 2 is intended to create a channel in totally occluded peripheral vessels. The device may also be used to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention. """

  AVINGER, INC.

  2019-03-21

• Kittykat II - """Kittycat 2 Catheter is a 5F sheath and 0.014” guidewire compatible over-the-wire device with a working length of 150 cm. It consists of a catheter shaft with handle assembly at the proximal end and an atraumatic Distal Tip. A locking Luer connecter at the proximal end provides entry to a lumen that supports and facilitates movement of a guidewire. The catheter has been irradiated for sterility and is intended for single use only.The Distal Tip houses Spiral Flutes and allows atraumatic advancement of the catheter through the vasculature. The pre-shaped Distal Tip is made of a malleable material and may be reshaped as needed by the user. The deflection of the Distal Tip is visible under fluoroscopic guidance.The handle assembly consists of a Handle Body, Rotator, and Luer. The Handle Body controls rotational orientation of the catheter, including the flexible Distal Tip. The Rotator controls the rotational movement of the Distal Tip, independent of the catheter orientation. The Luer is provided at the proximal end to facilitate fluid flush and the entry/exit of the guidewire. Kittycat 2 is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention. The Kittycat 2 Catheter is contraindicated for use in the iliac, coronary, cerebral or carotid vasculature.Kittycat 2 is intended to be used to support steerable guidewires in accessing discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. It may also be used to deliver saline or contrast."""

  AVINGER, INC.

  2019-03-21

• Wildcat - """The Wildcat CTO Catheter is intended to create a channel in totally occluded peripheral vessels. The device may also be used to faciliate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention. The Wildcat CTO Catheter is a 6F sheath and 0.035"""" guidewire compatible over-the-wire device. It consists of a catheter shaft with a handle assembly at the porximal end and an atraumatic Distal Tip. A locking Luer connector at the proximal end provides entry to a lumen that supports and facilitates movement of a guidewire. The catheter has been irradiated for sterility and is intended for single use only. At the Slider’s most proximal location, the Wedges are in the retracted position. At the mid-point location, the Wedges are deployed. Moving the slider distal from this point initiates deflection of the Distal Tip. The amount of tip deflection increases with distal movement of the slider. At the most distal location, the Wedges remain fully deployed and the Distal Tip is at maximum deflection. The deployment and retraction of the Wedges as well as the deflection of the Distal Tip is visible under fluoroscopic guidance.The handle assembly consists of a Handle Body, Rotator, Tip Indicator, Slider, and Luer. The Handle Body controls rotational orientation of the catheter, including the flexible Distal Tip. The Rotator controls the rotational movement of the Distal Tip, independent of the catheter orientation. Rotational movement of the Distal Tip can be achieved either with Wedges deployed or retracted. Luer is provided to facilitate fluid flush and the entry/exit of the guidewire. """

  AVINGER, INC.

  2019-03-21

• Wildcat - """The Wildcat CTO Catheter is intended to create a channel in totally occluded peripheral vessels. The device may also be used to faciliate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention. The Wildcat Catheter is contraindicated for use in the iliac, coronary, cerebral or carotid vasculature. The Wildcat Catheter is intended to be used to support steerable guidewires in accessing discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. It may also be used to deliver saline or contrast.The Wildcat CTO Catheter is a 6F sheath and 0.035"""" guidewire compatible over-the-wire device. It consists of a catheter shaft with a handle assembly at the porximal end and an atraumatic Distal Tip. A locking Luer connector at the proximal end provides entry to a lumen that supports and facilitates movement of a guidewire. The catheter has been irradiated for sterility and is intended for single use only. At the Slider’s most proximal location, the Wedges are in the retracted position. At the mid-point location, the Wedges are deployed. Moving the slider distal from this point initiates deflection of the Distal Tip. The amount of tip deflection increases with distal movement of the slider. At the most distal location, the Wedges remain fully deployed and the Distal Tip is at maximum deflection. The deployment and retraction of the Wedges as well as the deflection of the Distal Tip is visible under fluoroscopic guidance."

  AVINGER, INC.

  2019-03-21