| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00851354004370 | A400 | A400 | The Pantheris System is intended to remove plaque (atherectomy) from partially o 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. | NQQ,MCW | System, Imaging, Optical Coherence Tomography (Oct),Catheter, Peripheral, Atherectomy | 2 | Pantheris |
| 2 | 00851354004271 | C100 | C100 | The CO2 Regulator System is intended to supply low pressure CO2, where small vol 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). | CAN | Regulator, Pressure, Gas Cylinder | 1 | CO2 |
| 3 | 00851354004301 | U250 | U250 | Lightbox Umbilical is intended for use in peripheral vascular procedures in conj Lightbox Umbilical is intended for use in peripheral vascular procedures in conjunction with a compatible Avinger product. | NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 2 | Lightbox Umbilical |
| 4 | 00851354004141 | P135 | P135 | "The Ocelot PIXL System consists of the Ocelot PIXL Catheter (“Ocelot PIXL”), th "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. " | PDU | Catheter For Crossing Total Occlusions | 2 | Ocelot PIXL |
| 5 | 00851354004417 | A140-SV | A140-SV | The Pantheris SV System is intended to remove plaque (atherectomy) from partiall 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. | NQQ,MCW | System, Imaging, Optical Coherence Tomography (Oct),Catheter, Peripheral, Atherectomy | 2 | Pantheris SV |
| 6 | 00851354004233 | O250 | O250 | The Ocelot System is intended to facilitate the intraluminal placement of conven 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. | PDU | Catheter For Crossing Total Occlusions | 2 | Ocelot IV |
| 7 | 00851354004073 | J100 | J100 | Juicebox is an optional accessory to facilitate catheter tip rotation when using 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. | DQY | Catheter, Percutaneous | 2 | Juicebox |
| 8 | 00851354004059 | E550 | E550 | "Kittycat 2 Catheter is a 5F sheath and 0.014” guidewire compatible over-the-wi "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. " | DQY | Catheter, Percutaneous | 2 | Kittykat II |
| 9 | 00851354004042 | W550` | W550 | "Kittycat 2 Catheter is a 5F sheath and 0.014” guidewire compatible over-the-wi "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." | DQY | Catheter, Percutaneous | 2 | Kittykat II |
| 10 | 00851354004387 | A400X | A400X | The Pantheris System is intended to remove plaque (atherectomy) from partially o 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. | NQQ,MCW | System, Imaging, Optical Coherence Tomography (Oct),Catheter, Peripheral, Atherectomy | 2 | Pantheris |
| 11 | 00851354004264 | SD100 | SD100 | The Sterile Drape is designed to function as a protective barrier between the st The Sterile Drape is designed to function as a protective barrier between the sterile and non-sterile environments during surgical procedures | KKK | Sudan Iv | 1 | Sterile Drape |
| 12 | 00851354004189 | O200 | O200 | The Ocelot System is intended to facilitate the intraluminal placement of conven 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. | NQQ,DQY | System, Imaging, Optical Coherence Tomography (Oct),Catheter, Percutaneous | 2 | Ocelot III |
| 13 | 00851354004028 | E400 | E400 | "The Wildcat CTO Catheter is intended to create a channel in totally occluded pe "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. " | DQY | Catheter, Percutaneous | 2 | Wildcat |
| 14 | 00851354004004 | W400 | W400 | "The Wildcat CTO Catheter is intended to create a channel in totally occluded pe "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. | DQY | Catheter, Percutaneous | 2 | Wildcat |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00851354004233 | O250 | O250 | The Ocelot System is intended to facilitate the intraluminal placement of conven 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. | Ocelot IV | AVINGER, INC. |
| 2 | 00851354004141 | P135 | P135 | "The Ocelot PIXL System consists of the Ocelot PIXL Catheter (“Ocelot PIXL”), th "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. " | Ocelot PIXL | AVINGER, INC. |
| 3 | 00851354004127 | U100 | U100 | Lightbox Umbilical is intended for use in peripheral vascular procedures in conj Lightbox Umbilical is intended for use in peripheral vascular procedures in conjunction with a compatible Avinger product. | Lightbox Umbilical | AVINGER, INC. |
| 4 | 00845225002565 | PPLUS120 | Pioneer Plus Catheter | PHILIPS IMAGE GUIDED THERAPY CORPORATION | ||
| 5 | 00842362100031 | 101 | Percutaneous Catheter | DABRA 101 Catheter | RA MEDICAL SYSTEMS, INC. | |
| 6 | 00842362100024 | RA-308 | A mains electricity (AC-powered) Light Amplification by Stimulated Emission of R A mains electricity (AC-powered) Light Amplification by Stimulated Emission of Radiation (LASER) device assembly in which input energy is used to excite dimers (typically rare gas monohalides such as argon fluoride, xenon chloride) as the active medium to emit a beam of intense, coherent, monochromatic electromagnetic (EM) radiation (UVA and/or UVB) for endovascular therapy. It typically includes a light source, delivery catheter, and controls/foot-switch. It is typically intended to treat endovascular disease. | DABRA Laser System | RA MEDICAL SYSTEMS, INC. | |
| 7 | 00827002507937 | G50793 | CMW-14-300-25G | Approach, CTO-25 Micro Wire Guide | Approach | COOK INCORPORATED |
| 8 | 00827002507920 | G50792 | CMW-14-300-18G | Approach, CTO-18 Micro Wire Guide | Approach | COOK INCORPORATED |
| 9 | 00827002507913 | G50791 | CMW-14-300-12G | Approach, CTO-12 Micro Wire Guide | Approach | COOK INCORPORATED |
| 10 | 00827002507906 | G50790 | CMW-14-300-6G | Approach, CTO-6 Micro Wire Guide | Approach | COOK INCORPORATED |
| 11 | 00827002507890 | G50789 | CMW-14-190-25G | Approach, CTO-25 Micro Wire Guide | Approach | COOK INCORPORATED |
| 12 | 00827002507883 | G50788 | CMW-14-190-18G | Approach, CTO-18 Micro Wire Guide | Approach | COOK INCORPORATED |
| 13 | 00827002507876 | G50787 | CMW-14-190-12G | Approach, CTO-12 Micro Wire Guide | Approach | COOK INCORPORATED |
| 14 | 00827002507869 | G50786 | CMW-14-190-6G | Approach, CTO-6 Micro Wire Guide | Approach | COOK INCORPORATED |
| 15 | 00827002507852 | G50785 | CMW-14-135-25G | Approach, CTO-25 Micro Wire Guide | Approach | COOK INCORPORATED |
| 16 | 00827002507845 | G50784 | CMW-14-135-18G | Approach, CTO-18 Micro Wire Guide | Approach | COOK INCORPORATED |
| 17 | 00827002507838 | G50783 | CMW-14-135-12G | Approach, CTO-12 Micro Wire Guide | Approach | COOK INCORPORATED |
| 18 | 00827002507821 | G50782 | CMW-14-135-6G | Approach, CTO-6 Micro Wire Guide | Approach | COOK INCORPORATED |
| 19 | 00821684073841 | ENW-SF-014-300 | GW ENW-SF-014-300 CTO RE-ENTRY V03 | Enteer™ | COVIDIEN LP | |
| 20 | 00821684073834 | ENW-SD-014-300 | GW ENW-SD-014-300 CTO RE-ENTRY V03 | Enteer™ | COVIDIEN LP | |
| 21 | 00821684073827 | ENW-FX-014-300 | GW ENW-FX-014-300 CTO RE-ENTRY V03 | Enteer™ | COVIDIEN LP | |
| 22 | 00821684073797 | ENB-375-20-135 | CATH ENB-375-20-135 CTO RE-ENTRY V03 | Enteer™ | COVIDIEN LP | |
| 23 | 00821684073780 | ENB-275-20-150 | CATH ENB-275-20-150 CTO RE-ENTRY V03 | Enteer™ | COVIDIEN LP | |
| 24 | 00821684073759 | VNC-SD-150 | CATH VNC-SD-150 CTO CROSSING V05 | Viance™ | COVIDIEN LP | |
| 25 | 00821684073742 | VNC-FX-150 | CATH VNC-FX-150 CTO CROSSING V05 | Viance™ | COVIDIEN LP | |
| 26 | 00813132020286 | 518-063AA | 518-063 | Turbo-Booster™ Laser Guide Catheter | Turbo-Booster™ | SPECTRANETICS CORPORATION |
| 27 | 00813132020279 | 518-043AA | 518-043 | Turbo-Booster™ Laser Guide Catheter | Turbo-Booster™ | SPECTRANETICS CORPORATION |
| 28 | 00801741202452 | BDRECANSYSTEMS | BDRECANSYSTEMS | Recanalization System, Serviced | Recanalization System | BARD PERIPHERAL VASCULAR, INC. |
| 29 | 00801741202445 | BDRECANSYSTEML | BDRECANSYSTEML | Recanalization System, Loaner | Recanalization System | BARD PERIPHERAL VASCULAR, INC. |
| 30 | 00801741202438 | BDRECANSYSTEMR | BDRECANSYSTEMR | Recanalization System, Refurbished | Recanalization System | BARD PERIPHERAL VASCULAR, INC. |
| 31 | 00801741202421 | BDRECANSYSTEM | BDRECANSYSTEM | Recanalization System | Recanalization System | BARD PERIPHERAL VASCULAR, INC. |
| 32 | 00801741202414 | BDRECANFOOT | BDRECANFOOT | Recanalization System Footswitch | Recanalization System | BARD PERIPHERAL VASCULAR, INC. |
| 33 | 00801741201332 | XCTO146 | XCTO146 | Crosser iQ Ultrasonic CTO Device | Crosser iQ | BARD PERIPHERAL VASCULAR, INC. |
| 34 | 00801741067617 | GEN200 | GEN200 | CROSSER® Generator | CROSSER® | BARD PERIPHERAL VASCULAR, INC. |
| 35 | 00801741067471 | CRPEDAL | CRPEDAL | CROSSER® System Foot Switch | CROSSER® | BARD PERIPHERAL VASCULAR, INC. |
| 36 | 00685447001089 | EWK35-250-12-6A-20-05 | PowerWire RF GuideWire; RFP-100A Connector Cable | PowerWire Radiofrequency GuideWire Kit | BAYLIS MÉDICALE CIE INC | |
| 37 | 00685447001072 | EWK35-250-12-6A-30-05 | PowerWire RF GuideWire; RFP-100A Connector Cable | PowerWire Radiofrequency GuideWire Kit | BAYLIS MÉDICALE CIE INC | |
| 38 | 00685447001065 | EWK35-250-12-6A-40-12 | PowerWire RF GuideWire; RFP-100A Connector Cable | PowerWire Radiofrequency GuideWire Kit | BAYLIS MÉDICALE CIE INC | |
| 39 | 00685447001058 | EWK35-250-12-6S | PowerWire RF GuideWire; RFP-100A Connector Cable | PowerWire Radiofrequency GuideWire Kit | BAYLIS MÉDICALE CIE INC | |
| 40 | 00685447001041 | EWK35-250-10-6S | PowerWire RF GuideWire; RFP-100A Connector Cable | PowerWire Radiofrequency GuideWire Kit | BAYLIS MÉDICALE CIE INC | |
| 41 | 00685447001034 | EWK35-250-08-6S | PowerWire RF GuideWire; RFP-100A Connector Cable | PowerWire Radiofrequency GuideWire Kit | BAYLIS MÉDICALE CIE INC | |
| 42 | 20705032067574 | OTB59120A | OTB59120A | OUTBACK Elite 120cm Re-Entry | OUTBACK | CORDIS CORPORATION |
| 43 | 20705032067567 | OTB59080A | OTB59080A | OUTBACK Elite 80cm Re-Entry | OUTBACK | CORDIS CORPORATION |
| 44 | 20705032067536 | MGC39140X | MGC39140X | Support Catheter | ELITECROSS Support Catheter | CORDIS CORPORATION |
| 45 | 20705032067512 | MGC39140A | MGC39140A | Support Catheter | ELITECROSS Support Catheter | CORDIS CORPORATION |
| 46 | 20705032067505 | MGC39090X | MGC39090X | Support Catheter | ELITECROSS Support Catheter | CORDIS CORPORATION |
| 47 | 20705032067482 | MGC39090A | MGC39090A | Support Catheter | ELITECROSS Support Catheter | CORDIS CORPORATION |
| 48 | 20705032035016 | OTB42120 | OTB42120 | OUTBACK LTD 120cm Re-Entry | OUTBACK | CORDIS CORPORATION |
| 49 | 17540265105022 | 900-0001291 | The SoundBite® Curving Tool 14 is used by the Physician to curve the tip of the The SoundBite® Curving Tool 14 is used by the Physician to curve the tip of the active wire if desired. Its use is explained in the IFU. | SoundBite® Curving Tool 14 | SOUNDBITE MEDICAL SOLUTIONS INC | |
| 50 | 17540265103028 | 9AB-C001091 | The SoundBite® Console generates controlled high-amplitude short-duration mechan The SoundBite® Console generates controlled high-amplitude short-duration mechanical pulses (i.e., shock waves) which are transmitted to a connected SoundBite® Active Wire 14P and cause the distal tip of the active wire to move back and forth (axially), acting like a micro-jackhammer. After the passage of each pulse, the tip goes back to its original position. | SoundBite® Console | SOUNDBITE MEDICAL SOLUTIONS INC |