No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 20705032032183 | N1040SB | N1040SB | PRECISE BILIARY 10X40 | NIM | STENT, CAROTID | 3 | PRECISE |
2 | 20705032032046 | N1030SB | N1030SB | PRECISE BILIARY 10X30 | NIM | STENT, CAROTID | 3 | PRECISE |
3 | 20705032039588 | PG2960BSX | PG2960BSX | FGE | CATHETER, BILIARY, DIAGNOSTIC | 2 | PALMAZ GENESIS Transhepatic Biliary Stent on SLALOM .018" Delivery System | |
4 | 20705032075029 | SM6736 | SM6736 | GC 6F .067 100CM XB 5.0 | DQY | CATHETER, PERCUTANEOUS | 2 | VISTA BRITE TIP |
5 | 20705032035030 | P05020RXC | P05020RXC | NIM | STENT, CAROTID | 3 | Cordis PRECISE RX Nitinol Stent System | |
6 | 20705032024317 | C09020ML | C09020ML | NIP,NIO | STENT, SUPERFICIAL FEMORAL ARTERY,STENT, ILIAC | 3 | Cordis S.M.A.R.T. Control Vascular Stent System | |
7 | 20705032006023 | 435202X | 435202X | PTA SAVVY 2.00 X 2CM 150CM | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | SAVVY |
8 | 10705032057318 | P308M | P308M | MAF | STENT, CORONARY | 3 | PALMAZ Balloon Expandable Stent | |
9 | 10705032014533 | 534696T | 534696T | INF TL PROPAC FR6 | DQO | CATHETER, INTRAVASCULAR, DIAGNOSTIC | DUCOR | |
10 | 10705032009560 | 502144 | 502144 | CINCH QR | DQX | Wire, guide, catheter | 2 | CINCH |
11 | 20705032081204 | 48009002R | 48009002R | SABER .035 PTA Dilation Catheter 9mm x 20mm x 135cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
12 | 20705032081198 | 48012002R | 48012002R | SABER .035 PTA Dilation Catheter 12mm x 20mm x 135cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
13 | 20705032081181 | 48003008N | 48003008N | SABER .035 PTA Dilation Catheter 3mm x 80mm x 80cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
14 | 20705032081174 | 48009002N | 48009002N | SABER .035 PTA Dilation Catheter 9mm x 20mm x 80cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
15 | 20705032081167 | 48012002N | 48012002N | SABER .035 PTA Dilation Catheter 12mm x 20mm x 80cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
16 | 20705032081150 | 48003008P | 48003008P | SABER .035 PTA Dilation Catheter 3mm x 80mm x 40cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
17 | 20705032081143 | 48009002P | 48009002P | SABER .035 PTA Dilation Catheter 9mm x 20mm x 40cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
18 | 20705032081136 | 48012002P | 48012002P | SABER .035 PTA Dilation Catheter 12mm x 20mm x 40cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
19 | 20705032081129 | 48003008R | 48003008R | SABER .035 PTA Dilation Catheter 3mm x 80mm x 135cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
20 | 20705032081112 | 48010008N | 48010008N | SABER .035 PTA Dilation Catheter 10mm x 80mm x 80cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
21 | 20705032081105 | 48005006N | 48005006N | SABER .035 PTA Dilation Catheter 5mm x 60mm x 80cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
22 | 20705032081099 | 48008002R | 48008002R | SABER .035 PTA Dilation Catheter 8mm x 20mm x 135cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
23 | 20705032081082 | 48010008P | 48010008P | SABER .035 PTA Dilation Catheter 10mm x 80mm x 40cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
24 | 20705032081075 | 48005006P | 48005006P | SABER .035 PTA Dilation Catheter 5mm x 60mm x 40cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
25 | 20705032081068 | 48004015R | 48004015R | SABER .035 PTA Dilation Catheter 4mm x 150mm x 135cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
26 | 20705032081051 | 48010008R | 48010008R | SABER .035 PTA Dilation Catheter 10mm x 80mm x 135cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
27 | 20705032081044 | 48005012R | 48005012R | SABER .035 PTA Dilation Catheter 5mm x 120mm x 135cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
28 | 20705032081037 | 48005006R | 48005006R | SABER .035 PTA Dilation Catheter 5mm x 60mm x 135cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
29 | 20705032081020 | 48008002N | 48008002N | SABER .035 PTA Dilation Catheter 8mm x 20mm x 80cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
30 | 20705032081013 | 48005012P | 48005012P | SABER .035 PTA Dilation Catheter 5mm x 120mm x 40cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
31 | 20705032081006 | 48004015N | 48004015N | SABER .035 PTA Dilation Catheter 4mm x 150mm x 80cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
32 | 20705032080993 | 48008002P | 48008002P | SABER .035 PTA Dilation Catheter 8mm x 20mm x 40cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
33 | 20705032080986 | 48005012N | 48005012N | SABER .035 PTA Dilation Catheter 5mm x 120mm x 80cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
34 | 20705032080979 | 48007008P | 48007008P | SABER .035 PTA Dilation Catheter 7mm x 80mm x 40cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
35 | 20705032080962 | 48007008N | 48007008N | SABER .035 PTA Dilation Catheter 7mm x 80mm x 80cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
36 | 20705032080955 | 48007008R | 48007008R | SABER .035 PTA Dilation Catheter 7mm x 80mm x 135cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
37 | 20705032080948 | 48009010N | 48009010N | SABER .035 PTA Dilation Catheter 9mm x 100mm x 80cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
38 | 20705032080931 | 48003020N | 48003020N | SABER .035 PTA Dilation Catheter 3mm x 200mm x 80cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
39 | 20705032080924 | 48004004N | 48004004N | SABER .035 PTA Dilation Catheter 4mm x 40mm x 80cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
40 | 20705032080917 | 48009010P | 48009010P | SABER .035 PTA Dilation Catheter 9mm x 100mm x 40cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
41 | 20705032080900 | 48004004R | 48004004R | SABER .035 PTA Dilation Catheter 4mm x 40mm x 135cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
42 | 20705032080894 | 48004004P | 48004004P | SABER .035 PTA Dilation Catheter 4mm x 40mm x 40cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
43 | 20705032080887 | 48003010R | 48003010R | SABER .035 PTA Dilation Catheter 3mm x 100mm x 135cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
44 | 20705032080870 | 48006012P | 48006012P | SABER .035 PTA Dilation Catheter 6mm x 120mm x 40cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
45 | 20705032080863 | 48006006R | 48006006R | SABER .035 PTA Dilation Catheter 6mm x 60mm x 135cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
46 | 20705032080856 | 48003010P | 48003010P | SABER .035 PTA Dilation Catheter 3mm x 100mm x 40cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
47 | 20705032080849 | 48006012R | 48006012R | SABER .035 PTA Dilation Catheter 6mm x 120mm x 135cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
48 | 20705032080832 | 48006006P | 48006006P | SABER .035 PTA Dilation Catheter 6mm x 60mm x 40cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
49 | 20705032080825 | 48009010R | 48009010R | SABER .035 PTA Dilation Catheter 9mm x 100mm x 135cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
50 | 20705032080818 | 48006006N | 48006006N | SABER .035 PTA Dilation Catheter 6mm x 60mm x 80cm | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | Saber .035 |
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 |