No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00842429100912 | 212922-LVIS-D-PMA | 212922-LVIS | Stent | QCA | Intracranial Coil-Assist Stent | 3 | LVIS |
2 | 00842429101582 | ISC5115ST | ISC5115ST | DQY | Catheter, Percutaneous | 2 | Sofia EX 5F - 115cm STR | |
3 | 00842429100981 | 214049-LVIS-D-PMA | 214049-LVIS | Stent | QCA | Intracranial Coil-Assist Stent | 3 | LVIS |
4 | 00842429100974 | 214035-LVIS-D-PMA | 214035-LVIS | Stent | QCA | Intracranial Coil-Assist Stent | 3 | LVIS |
5 | 00842429100967 | 213041-LVIS-D-PMA | 213041-LVIS | Stent | QCA | Intracranial Coil-Assist Stent | 3 | LVIS |
6 | 00842429100950 | 213025-LVIS-D-PMA | 213025-LVIS | Stent | QCA | Intracranial Coil-Assist Stent | 3 | LVIS |
7 | 00842429100943 | 213015-LVIS-D-PMA | 213015-LVIS | Stent | QCA | Intracranial Coil-Assist Stent | 3 | LVIS |
8 | 00842429100936 | 212931-LVIS-D-PMA | 212931-LVIS | Stent | QCA | Intracranial Coil-Assist Stent | 3 | LVIS |
9 | 00842429100929 | 212928-LVIS-D-PMA | 212928-LVIS | Stent | QCA | Intracranial Coil-Assist Stent | 3 | LVIS |
10 | 00842429100905 | 212917-LVIS-D-PMA | 212917-LVIS | Stent | QCA | Intracranial Coil-Assist Stent | 3 | LVIS |
11 | 00842429100899 | 212912-LVIS-D-PMA | 212912-LVIS | Stent | QCA | Intracranial Coil-Assist Stent | 3 | LVIS |
12 | 00842429100882 | 212525-LVIS-D-PMA | 212525-LVIS | Stent | QCA | Intracranial Coil-Assist Stent | 3 | LVIS |
13 | 00842429100875 | 212517-LVIS-D-PMA | 212517-LVIS | Stent | QCA | Intracranial Coil-Assist Stent | 3 | LVIS |
14 | 00816777027139 | 100623HFRM-V-A | 100623HFRM-V | V-Trak | KRD | Device, Vascular, for Promoting Embolization | 2 | HydroFrame Framing Coil |
15 | 00816777027108 | 100519HFRM-V-A | 100519HFRM-V | V-Trak | KRD | Device, Vascular, for Promoting Embolization | 2 | HydroFrame Framing Coil |
16 | 00816777026590 | 100310HFRM-V-3D-A2 | 100310HFRM-V | V-Trak | KRD | Device, Vascular, for Promoting Embolization | 2 | HydroSoft 3D |
17 | 00816777026583 | 100308HFRM-V-3D-A2 | 100308HFRM-V | V-Trak | KRD | Device, Vascular, for Promoting Embolization | 2 | HydroSoft 3D |
18 | 00816777026576 | 100306HFRM-V-3D-A2 | 100306HFRM-V | V-Trak | KRD | Device, Vascular, for Promoting Embolization | 2 | HydroSoft 3D |
19 | 00816777026569 | 100304HFRM-V-3D-A2 | 100304HFRM-V | V-Trak | KRD | Device, Vascular, for Promoting Embolization | 2 | HydroSoft 3D |
20 | 00816777026545 | 100256HFRM-V-3D-A2 | 100256HFRM-V | V-Trak | KRD | Device, Vascular, for Promoting Embolization | 2 | HydroSoft 3D |
21 | 00816777026538 | 100254HFRM-V-3D-A2 | 100254HFRM-V | V-Trak | HCG | DEVICE, NEUROVASCULAR EMBOLIZATION | 2 | HydroSoft 3D |
22 | 00816777026521 | 100208HFRM-V-3D-A2 | 100208HFRM-V | V-Trak | KRD | Device, Vascular, for Promoting Embolization | 2 | HydroSoft 3D |
23 | 00816777026514 | 100206HFRM-V-3D-A2 | 100206HFRM-V | V-Trak | KRD | Device, Vascular, for Promoting Embolization | 2 | HydroSoft 3D |
24 | 00816777026507 | 100204HFRM-V-3D-A2 | 100204HFRM-V | V-Trak | KRD | Device, Vascular, for Promoting Embolization | 2 | HydroSoft 3D |
25 | 00816777026491 | 100203HFRM-V-3D-A2 | 100203HFRM-V | V-Trak | KRD | Device, Vascular, for Promoting Embolization | 2 | HydroSoft 3D |
26 | 00816777026484 | 100202HFRM-V-3D-A2 | 100202HFRM-V | V-Trak | HCG | DEVICE, NEUROVASCULAR EMBOLIZATION | 2 | HydroSoft 3D |
27 | 00816777026477 | 100154HFRM-V-3D-A2 | 100154HFRM-V | V-Trak | KRD | Device, Vascular, for Promoting Embolization | 2 | HydroSoft 3D |
28 | 00816777026453 | 100152HFRM-V-3D-A2 | 100152HFRM-V | V-Trak | KRD | Device, Vascular, for Promoting Embolization | 2 | HydroSoft 3D |
29 | 00816777026446 | 100103HFRM-V-3D-A2 | 100103HFRM-V | V-Trak | KRD | Device, Vascular, for Promoting Embolization | 2 | HydroSoft 3D |
30 | 00816777026439 | 100102HFRM-V-3D-A2 | 100102HFRM-V | V-Trak | KRD | Device, Vascular, for Promoting Embolization | 2 | HydroSoft 3D |
31 | 00812636022215 | 213025-LVIS-D-HDE | 213025-LVIS | Stent | NJE | intracranial neurovascular stent | LVIS | |
32 | 00816777026026 | 212931-LVIS-D-HDE | 212931-LVIS | Stent | NJE | intracranial neurovascular stent | LVIS | |
33 | 00816777026019 | 212928-LVIS-D-HDE | 212928-LVIS | Stent | NJE | intracranial neurovascular stent | LVIS | |
34 | 00816777026002 | 212922-LVIS-D-HDE | 212922-LVIS | Stent | NJE | intracranial neurovascular stent | LVIS | |
35 | 00816777025999 | 212917-LVIS-D-HDE | 212917-LVIS | Stent | NJE | intracranial neurovascular stent | LVIS | |
36 | 00816777025982 | 212912-LVIS-D-HDE | 212912-LVIS | Stent | NJE | intracranial neurovascular stent | LVIS | |
37 | 00816777025838 | MCWED21160 | MCWED21160 | Microcatheter | DQY | Catheter, percutaneous | 2 | Wedge |
38 | 00816777025487 | 7110-0310-3D-A2 | 7110-0310 | V-Trak | KRD | Device, Vascular, for Promoting Embolization | 2 | HydroSoft 3D |
39 | 00816777025470 | 7110-0308-3D-A2 | 7110-0308 | V-Trak | KRD | Device, Vascular, for Promoting Embolization | 2 | HydroSoft 3D |
40 | 00816777025456 | 7110-0304-3D-A2 | 7110-0304 | V-Trak | KRD | Device, Vascular, for Promoting Embolization | 2 | HydroSoft 3D |
41 | 00816777025449 | 7110-0258-3D-A2 | 7110-0258 | V-Trak | KRD | Device, Vascular, for Promoting Embolization | 2 | HydroSoft 3D |
42 | 00816777025432 | 7110-0256-3D-A2 | 7110-0256 | V-Trak | KRD | Device, Vascular, for Promoting Embolization | 2 | HydroSoft 3D |
43 | 00816777025418 | 7110-0210-3D-A2 | 7110-0210 | V-Trak | KRD | Device, Vascular, for Promoting Embolization | 2 | HydroSoft 3D |
44 | 00816777025401 | 7110-0208-3D-A2 | 7110-0208 | V-Trak | KRD | Device, Vascular, for Promoting Embolization | 2 | HydroSoft 3D |
45 | 00816777025395 | 7110-0206-3D-A2 | 7110-0206 | V-Trak | KRD | Device, Vascular, for Promoting Embolization | 2 | HydroSoft 3D |
46 | 00816777025388 | 7110-0204-3D-A2 | 7110-0204 | V-Trak | KRD | Device, Vascular, for Promoting Embolization | 2 | HydroSoft 3D |
47 | 00816777025371 | 7110-0203-3D-A2 | 7110-0203 | V-Trak | KRD | Device, Vascular, for Promoting Embolization | 2 | HydroSoft 3D |
48 | 00816777025357 | 7110-0154-3D-A2 | 7110-0154 | V-Trak | KRD | Device, Vascular, for Promoting Embolization | 2 | HydroSoft 3D |
49 | 00816777025340 | 7110-0153-3D-A2 | 7110-0153 | V-Trak | KRD | Device, Vascular, for Promoting Embolization | 2 | HydroSoft 3D |
50 | 00816777025333 | 7110-0152-3D-A2 | 7110-0152 | V-Trak | KRD | Device, Vascular, for Promoting Embolization | 2 | HydroSoft 3D |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 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. | Ocelot III | AVINGER, INC. |
2 | 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. | Juicebox | AVINGER, INC. |
3 | 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. " | Kittykat II | AVINGER, INC. |
4 | 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." | Kittykat II | AVINGER, INC. |
5 | 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. " | Wildcat | AVINGER, INC. |
6 | 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. | Wildcat | AVINGER, INC. |
7 | 00850025525091 | SPN35150US | Spex Shapeable Support Catheter, 35 X 150cm, US | SPEX35 | REFLOW MEDICAL, INC. | |
8 | 00850025525084 | SPN35135US | Spex Shapeable Support Catheter, 35 X 135cm, US | SPEX35 | REFLOW MEDICAL, INC. | |
9 | 00850025525077 | SPN35090US | Spex Shapeable Support Catheter, 35 X 90cm, US | SPEX35 | REFLOW MEDICAL, INC. | |
10 | 00850025525060 | SPN35050US | Spex Shapeable Support Catheter, 35 X 50cm, US | SPEX35 | REFLOW MEDICAL, INC. | |
11 | 00850025525053 | CRX14150US | Cora Cross Coronary Crossing Catheter 14X150cm | coraCross | REFLOW MEDICAL, INC. | |
12 | 00850025525046 | CRX14135US | Cora Cross Coronary Crossing Catheter 14X135cm | coraCross | REFLOW MEDICAL, INC. | |
13 | 00850025525039 | SLP35150US | speX LP Shapeable Support Catheter, 35 X 150cm, US | Spex LP | REFLOW MEDICAL, INC. | |
14 | 00850025525022 | SLP35135US | speX LP Shapeable Support Catheter, 35 X 135cm, US | Spex LP | REFLOW MEDICAL, INC. | |
15 | 00850025525015 | SLP35090US | speX LP Shapeable Support Catheter, 35 X 90cm, US | Spex LP | REFLOW MEDICAL, INC. | |
16 | 00847536044197 | REACT-71 | CATHETER REACT-71 V03 eIFU | REACT™ | MICRO THERAPEUTICS, INC. | |
17 | 00847536041967 | REACT-68 | CATHETER REACT-68 V03 eIFU | REACT™ | MICRO THERAPEUTICS, INC. | |
18 | 00847536041950 | FG19135-1030-1S | CATHETER FG19135-1030-1S V04 | PhenomTM Plus Catheter | MICRO THERAPEUTICS, INC. | |
19 | 00847536041943 | FG19135-0615-1S | CATHETER FG19135-0615-1S V04 | PhenomTM Plus Catheter | MICRO THERAPEUTICS, INC. | |
20 | 00847536041936 | FG19120-1030-1S | CATHETER FG19120-1030-1S V04 | PhenomTM Plus Catheter | MICRO THERAPEUTICS, INC. | |
21 | 00847536041929 | FG19120-1015-1S | CATHETER FG19120-1015-1S V04 | PhenomTM Plus Catheter | MICRO THERAPEUTICS, INC. | |
22 | 00847536041912 | FG19120-0630-1S | CATHETER FG19120-0630-1S V04 | PhenomTM Plus Catheter | MICRO THERAPEUTICS, INC. | |
23 | 00847536041905 | FG19105-0630-1S | CATHETER FG19105-0630-1S V04 | PhenomTM Plus Catheter | MICRO THERAPEUTICS, INC. | |
24 | 00847536041899 | FG19105-0615-1S | CATHETER FG19105-0615-1S V04 | PhenomTM Plus Catheter | MICRO THERAPEUTICS, INC. | |
25 | 00847536041882 | FG15160-0615-1S | CATHETER FG15160-0615-1S V04 | PhenomTM 27 Catheter | MICRO THERAPEUTICS, INC. | |
26 | 00847536041875 | FG15150-0630-1S | CATHETER FG15150-0630-1S V04 | PhenomTM 27 Catheter | MICRO THERAPEUTICS, INC. | |
27 | 00847536041868 | FG15150-0615-1S | CATHETER FG15150-0615-1S V04 | PhenomTM 27 Catheter | MICRO THERAPEUTICS, INC. | |
28 | 00847536041851 | FG15135-0615-1S | CATHETER FG15135-0615-1S V04 | PhenomTM 27 Catheter | MICRO THERAPEUTICS, INC. | |
29 | 00847536041844 | FG13160-0615-1S | CATHETER FG13160-0615-1S V04 | PhenomTM 21 Catheter | MICRO THERAPEUTICS, INC. | |
30 | 00847536041837 | FG13150-1015-2S | CATHETER FG13150-1015-2S V04 | PhenomTM 21 Catheter | MICRO THERAPEUTICS, INC. | |
31 | 00847536041820 | FG13150-0615-2X | CATHETER FG13150-0615-2X V04 | PhenomTM 21 Catheter | MICRO THERAPEUTICS, INC. | |
32 | 00847536041813 | FG13150-0615-2S | CATHETER FG13150-0615-2S V04 | PhenomTM 21 Catheter | MICRO THERAPEUTICS, INC. | |
33 | 00847536041806 | FG13150-0615-2R | CATHETER FG13150-0615-2R V04 | PhenomTM 21 Catheter | MICRO THERAPEUTICS, INC. | |
34 | 00847536041790 | FG13150-0615-2J | CATHETER FG13150-0615-2J V04 | PhenomTM 21 Catheter | MICRO THERAPEUTICS, INC. | |
35 | 00847536041783 | FG11160-0615-2X | CATHETER FG11160-0615-2X V04 | PhenomTM 17 Catheter | MICRO THERAPEUTICS, INC. | |
36 | 00847536041776 | FG11160-0615-2S | CATHETER FG11160-0615-2S V04 | PhenomTM 17 Catheter | MICRO THERAPEUTICS, INC. | |
37 | 00847536041769 | FG11160-0615-2R | CATHETER FG11160-0615-2R V04 | PhenomTM 17 Catheter | MICRO THERAPEUTICS, INC. | |
38 | 00847536041752 | FG11160-0615-2J | CATHETER FG11160-0615-2J V04 | PhenomTM 17 Catheter | MICRO THERAPEUTICS, INC. | |
39 | 00847536041745 | FG11160-0615-1S | CATHETER FG11160-0615-1S V04 | PhenomTM 17 Catheter | MICRO THERAPEUTICS, INC. | |
40 | 00847536041738 | FG11150-0615-2X | CATHETER FG11150-0615-2X V04 | PhenomTM 17 Catheter | MICRO THERAPEUTICS, INC. | |
41 | 00847536041721 | FG11150-0615-2S | CATHETER FG11150-0615-2S V04 | PhenomTM 17 Catheter | MICRO THERAPEUTICS, INC. | |
42 | 00847536041714 | FG11150-0615-2R | CATHETER FG11150-0615-2R V04 | PhenomTM 17 Catheter | MICRO THERAPEUTICS, INC. | |
43 | 00847536041707 | FG11150-0615-2J | CATHETER FG11150-0615-2J V04 | PhenomTM 17 Catheter | MICRO THERAPEUTICS, INC. | |
44 | 00847536031784 | REACT-71 | CATHETER REACT-71 US V01 | ReactTM | MICRO THERAPEUTICS, INC. | |
45 | 00847536031777 | REACT-68 | CATHETER REACT-68 US V01 | ReactTM | MICRO THERAPEUTICS, INC. | |
46 | 00847536024625 | ARC-160 | CATHETER ARC-160 MINI V02 US CANADA | ArcTM | MICRO THERAPEUTICS, INC. | |
47 | 00847536024618 | ARC-132 | CATHETER ARC-132 V02 US CANADA | ArcTM | MICRO THERAPEUTICS, INC. | |
48 | 00847536021945 | MIC-021-150 | MICROCATHETER MIC-021-150 REVERSE | ReverseTM | REVERSE MEDICAL CORPORATION | |
49 | 00847536018044 | RFX072-95-08MP | RFX072-95-08MP DCS CATHETERS FG | NavienTM | MICRO THERAPEUTICS, INC. | |
50 | 00847536018020 | RFX072-95-08 | RFX072-95-08 DCS CATHETERS FG | NavienTM | MICRO THERAPEUTICS, INC. |