Other products from "SPECTRANETICS CORPORATION"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00813132020187 425-011AA 425-011 Turbo-Elite™ Laser Atherectomy Catheter MCW Catheter, Peripheral, Atherectomy 2 Turbo-Elite™
2 00813132020170 423-001AA 423-001 Turbo-Elite™ Laser Atherectomy Catheter MCW Catheter, Peripheral, Atherectomy 2 Turbo-Elite™
3 00813132020163 420-159AA 420-159 Turbo-Elite™ Laser Atherectomy Catheter MCW Catheter, Peripheral, Atherectomy 2 Turbo-Elite™
4 00813132020156 420-006AA 420-006 Turbo-Elite™ Laser Atherectomy Catheter MCW Catheter, Peripheral, Atherectomy 2 Turbo-Elite™
5 00813132020149 417-156AA 417-156 Turbo-Elite™ Laser Atherectomy Catheter MCW Catheter, Peripheral, Atherectomy 2 Turbo-Elite™
6 00813132020132 417-152AA 417-152 Turbo-Elite™ Laser Atherectomy Catheter MCW Catheter, Peripheral, Atherectomy 2 Turbo-Elite™
7 00813132020125 414-159AA 414-159 Turbo-Elite™ Laser Atherectomy Catheter MCW Catheter, Peripheral, Atherectomy 2 Turbo-Elite™
8 00813132020118 414-151AA 414-151 Turbo-Elite™ Laser Atherectomy Catheter MCW Catheter, Peripheral, Atherectomy 2 Turbo-Elite™
9 00813132020101 410-154AA 410-154 Turbo-Elite™ Laser Atherectomy Catheter MCW Catheter, Peripheral, Atherectomy 2 Turbo-Elite™
10 00813132020095 410-152AA 410-152 Turbo-Elite™ Laser Atherectomy Catheter MCW Catheter, Peripheral, Atherectomy 2 Turbo-Elite™
11 M2045180390 518-039 518-039 Lead Locking Device (LLD E) DRB Stylet, Catheter 2 LLD™E
12 M2044250010 425-011 425-011 Turbo-Elite™ Laser Atherectomy Catheter MCW Catheter, Peripheral, Atherectomy 2 Turbo-Elite™
13 M2044230010 423-001 423-001 Turbo-Elite™ Laser Atherectomy Catheter MCW Catheter, Peripheral, Atherectomy 2 Turbo-Elite™
14 M2044201590 420-159 420-159 Turbo-Elite™ Laser Atherectomy Catheter MCW Catheter, Peripheral, Atherectomy 2 Turbo-Elite™
15 M2044200060 420-006 420-006 Turbo-Elite™ Laser Atherectomy Catheter MCW Catheter, Peripheral, Atherectomy 2 Turbo-Elite™
16 M2044171560 417-156 417-156 Turbo-Elite™ Laser Atherectomy Catheter MCW Catheter, Peripheral, Atherectomy 2 Turbo-Elite™
17 M2044171520 417-152 417-152 Turbo-Elite™ Laser Atherectomy Catheter MCW Catheter, Peripheral, Atherectomy 2 Turbo-Elite™
18 M2044141590 414-159 414-159 Turbo-Elite™ Laser Atherectomy Catheter MCW Catheter, Peripheral, Atherectomy 2 Turbo-Elite™
19 M2044141510 414-151 414-151 Turbo-Elite™ Laser Atherectomy Catheter MCW Catheter, Peripheral, Atherectomy 2 Turbo-Elite™
20 M2044101540 410-154 410-154 Turbo-Elite™ Laser Atherectomy Catheter MCW Catheter, Peripheral, Atherectomy 2 Turbo-Elite™
21 M2044101520 410-152 410-152 Turbo-Elite™ Laser Atherectomy Catheter MCW Catheter, Peripheral, Atherectomy 2 Turbo-Elite™
22 00813132020477 518-078AA 518-078 Quick-Cross™Extreme™ Support Catheter DQY Catheter, Percutaneous Quick-Cross™Extreme™
23 00813132020460 518-077AA 518-077 Quick-Cross™Select Support Catheter DQY Catheter, Percutaneous Quick-Cross™Select
24 00813132020453 518-076AA 518-076 Quick-Cross™Extreme™ Support Catheter DQY Catheter, Percutaneous Quick-Cross™Extreme™
25 00813132020316 500-013AA 500-013 SLS™II Laser Sheath MFA Device, Removal, Pacemaker Electrode, Percutaneous 3 SLS™II
26 00813132020309 500-012AA 500-012 SLS™II Laser Sheath MFA Device, Removal, Pacemaker Electrode, Percutaneous 3 SLS™II
27 00813132020293 500-001AA 500-001 SLS™II Laser Sheath MFA Device, Removal, Pacemaker Electrode, Percutaneous 3 SLS™II
28 00813132024970 AB35SX040100080 AB35SX040100080 Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon ONU Drug-Eluting Peripheral Transluminal Angioplasty Catheter 3 Stellarex™
29 00813132024840 590-001AB 590-001 Bridge Occlusion Catheter - 80 mm Length Balloon MJN Catheter, Intravascular Occluding, Temporary 2 Bridge™
30 00813132024666 590-001AA 590-001 Bridge Occlusion Catheter - 80 mm Length Balloon MJN Catheter, Intravascular Occluding, Temporary 2 Bridge™
31 00813132022259 518-076AB 518-076 Quick-Cross™Extreme™ Support Catheter DQY Catheter, Percutaneous Quick-Cross™Extreme™
32 00813132020941 555-508AA 555-508 SightRail™ Manual Dilator Sheath DRE Dilator, Vessel, For Percutaneous Catheterization 2 SightRail™
33 00813132021795 518-093AB 518-093 Quick-Cross™Select Support Catheter DQY Catheter, Percutaneous Quick-Cross™Select
34 00813132021788 518-092AB 518-092 Quick-Cross™Extreme™ Support Catheter DQY Catheter, Percutaneous Quick-Cross™Extreme™
35 00813132021771 518-091AB 518-091 Quick-Cross™Select Support Catheter DQY Catheter, Percutaneous Quick-Cross™Select
36 00813132021764 518-090AB 518-090 Quick-Cross™Extreme™ Support Catheter DQY Catheter, Percutaneous Quick-Cross™Extreme™
37 00813132021757 518-089AB 518-089 Quick-Cross™Select Support Catheter DQY Catheter, Percutaneous Quick-Cross™Select
38 00813132021740 518-088AB 518-088 Quick-Cross™Extreme™ Support Catheter DQY Catheter, Percutaneous Quick-Cross™Extreme™
39 00813132021733 518-087AB 518-087 Quick-Cross™Select Support Catheter DQY Catheter, Percutaneous Quick-Cross™Select
40 00813132021726 518-086AB 518-086 Quick-Cross™Extreme™ Support Catheter DQY Catheter, Percutaneous Quick-Cross™Extreme™
41 00813132021719 518-085AB 518-085 Quick-Cross™Select Support Catheter DQY Catheter, Percutaneous Quick-Cross™Select
42 00813132021702 518-084AB 518-084 Quick-Cross™Extreme™ Support Catheter DQY Catheter, Percutaneous Quick-Cross™Extreme™
43 00813132021696 518-083AB 518-083 Quick-Cross™Select Support Catheter DQY Catheter, Percutaneous Quick-Cross™Select
44 00813132021689 518-082AB 518-082 Quick-Cross™Extreme™ Support Catheter DQY Catheter, Percutaneous Quick-Cross™Extreme™
45 00813132021672 518-081AB 518-081 Quick-Cross™Select Support Catheter DQY Catheter, Percutaneous Quick-Cross™Select
46 00813132021665 518-080AB 518-080 Quick-Cross™Extreme™ Support Catheter DQY Catheter, Percutaneous Quick-Cross™Extreme™
47 00813132021481 518-079AB 518-079 Quick-Cross™Select Support Catheter DQY Catheter, Percutaneous Quick-Cross™Select
48 00813132021474 518-078AB 518-078 Quick-Cross™Extreme™ Support Catheter DQY Catheter, Percutaneous Quick-Cross™Extreme™
49 00813132021467 518-077AB 518-077 Quick-Cross™Select Support Catheter DQY Catheter, Percutaneous Quick-Cross™Select
50 00813132020996 519-106AA 519-106 Quick-Cross™ Capture™ Guidewire Retriever DQY Catheter, Percutaneous 2 Quick-Cross™ Capture™
Other products with the same Product Code "PDU"
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