Dialysis Access Devices

611 devices 31 with evidence

Clinical Overview

Dialysis access devices are critical for patients with end-stage renal disease requiring hemodialysis. These devices facilitate efficient blood filtration and waste removal, addressing renal insufficiency. Typically, nephrologists, interventional radiologists, and vascular surgeons are involved in the placement and management of these devices.
Clear Filters
Device Manufacturer Pathway Cleared Evidence
Phoenix Hemodialysis Delivery System Evidence Gambro Renal Products 510(k) 2011 8
Phoenix Hemodialysis Delivery System Version 3 35 Evidence Gambro 510(k) 2007 8
Phoenix Hemodialysis Delivery System Gambro Cartridge for Hemodialysis Blood Tubing Set Gambro Renal Products 510(k) 2000 8
14 5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve Palindrome Sapphire Evidence Kendall 510(k) 2006 7
Palindrome 14 5 Fr Chronic Hemodialysis Catheter Kendall 510(k) 2004 7
Palindrome Emerald 14 5 Fr Chronic Hemodialysis Catheter with Heparin Coating Tyco Healthcare Group 510(k) 2006 7
Kedall 14 5 Fr Chronic Hemodialysis Catheter W Silver Impregnated Sleeve Palindrome Ruby Kendall 510(k) 2006 7
Palindrome P Hemodialysis Catheter Evidence Covidien Lp, Formerly Registered As Kendall 510(k) 2009 7
Smart Segmentation Knowledge Based Contouring Evidence Varian Medical Systems 510(k) 2014 β€”
Konrad Model V 2 0 Evidence Mrc Systems 510(k) 2002 β€”
Water Purification System for Hemodialysis Evidence Usfilter/Ionpure 510(k) 1998 β€”
Radiance V5 Gmv Soluciones Globales Internet S.A.U. 510(k) 2024 β€”
Rayautoplan 1 0 Evidence Raysearch Laboratories Ab 510(k) 2009 β€”
Hemodialysis Venous Blood Tubing Set or Similar Trade Name Evidence National Medical Care 510(k) 1997 β€”
Nipro Safetouch Tulip Safety Fistula Needle Nipro Medical 510(k) 2007 β€”
Explorer 4d Treatment Planning System American Radiosurgery 510(k) 2010 β€”
Panther Tps Evidence Prowess 510(k) 2023 β€”
Simuplan Treatment Planning System Model V 7 5 Evidence Simuplan S.L. 510(k) 2003 β€”
Shelly Protected AV Fistula Needle Diasol 510(k) 1999 β€”
Schaefer Water Center Hemodialysis Water Purification System Model Hwps-100 Evidence Schaefer Water Centers 510(k) 2000 β€”
Hemodialysis System and Accessory Evidence Gainor Medical Europe 510(k) 1990 β€”
Preciseplan 2 0 Precision Therapy Intl. 510(k) 2002 β€”
Step-Tip Chronic Hemodialysis Catheter Evidence Arrow International 510(k) 2004 β€”
Hemodialysis Blood Tubing Set Evidence National Medical Care, Medical Products Div. 510(k) 1992 β€”
Duraspan Hemodialysis Long-Term Catheter Models 62152420 621512820 62153220 62153620 62154020 62155520 Evidence R4 Vascular 510(k) 2010 β€”
Jms Caveo a V Fistula Needle Set Jms North America 510(k) 2025 β€”
Radionics Xknife Hdrt System Integra Radionics 510(k) 2009 β€”
Radiance V2 Evidence Gmv Soluciones Globales Internet S.A.U. 510(k) 2014 β€”
Lifesite Hemodialysis Access System Cannula Exchange Kit Insertion Kit Access Cannila Evidence Vasca 510(k) 2003 β€”
Spot Pro 220v Model 131 099 Nucletron 510(k) 2002 β€”
15 5f Hemo-Stream Hemodialysis Catheter Set Evidence Rex Medical 510(k) 2007 β€”
Single Needle Hemodialysis Evidence Sorensen Research 510(k) 1976 β€”
Simuplan Treatment Planning System Evidence Simuplan S.L. 510(k) 2009 β€”
Panther Stereotactic Evidence Prowess 510(k) 2020 β€”
AngioDynamics Inc More-Flow Hemodialysis Catheter and Procedure Kit Angiodynamics 510(k) 2004 β€”
Vivamed Fistula Needle S.S. Ent. 510(k) 1992 β€”
Subclavian Hemodialysis Cath W Vitacuff Device Bd Becton Dickinson Vacutainer Systems Preanalytic 510(k) 1989 β€”
Ultrapure Water Treatment System for Hemodialysis Evidence Dayton Water Systems 510(k) 1998 β€”
Nipro Safetouch Safety Fistula Needle Nipro Medical 510(k) 2000 β€”
Hemodialysis Concentrate Solution Evidence Mid Atlantic Nephrology Center 510(k) 1980 β€”
P D Software Evidence .Decimal 510(k) 2009 β€”
Modification to Prowess Pro-Sim Evidence Ssgi Prowess Systems 510(k) 1998 β€”
Eclipse Treatment Planning System Evidence
Other clearances: 2014, 2010
Varian Medical Systems 510(k) 2017 β€”
Oncospace Evidence Oncospace 510(k) 2021 β€”
Dbb-06 Hemodialysis Delivery System Evidence Nikkiso 510(k) 2016 β€”
Bvm Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors Fresenius Medical Care North America, Design Cente 510(k) 2012 β€”
Cyberknife System for Sterotactic Radiosurgery Radiotherapy Accuray 510(k) 2003 β€”
Dayton Water Systems Ultrapure Water Treatment Systems for Hemodialysis Dayton Water Systems 510(k) 2002 β€”

Evidence Landscape

The clinical evidence for dialysis access devices spans randomized controlled trials, registry data, and case series. Commonly measured outcomes include device patency, infection rates, and patient quality of life. Evidence is robust for certain devices, while others require further investigation, particularly in long-term outcomes.

Device Landscape

Dialysis access devices include hemodialysis systems, blood tubing sets, and fistula needle sets, among others. Key features differentiating these devices include needle gauge, tubing material, and system compatibility, tailored to patient-specific vascular access needs.

Clinical Workflow Considerations

Dialysis access procedures are typically performed in hospital or outpatient settings, requiring specialized training in vascular access techniques. Considerations include device selection based on patient anatomy and institutional protocols, with emphasis on maintaining sterile technique and minimizing procedural complications.

Frequently Asked Questions

What are dialysis access devices used for?

Dialysis access devices are used to facilitate hemodialysis in patients with renal failure, allowing for the removal of waste products and excess fluid from the blood.

What clinical evidence is available for dialysis access devices?

The evidence includes randomized controlled trials, registry studies, and case series, focusing on outcomes like device longevity, infection rates, and patient satisfaction.

How do I choose between different dialysis access devices?

Clinicians consider patient-specific factors such as vascular anatomy, comorbidities, and previous access history, as well as institutional resources and expertise.

What complications are associated with dialysis access devices?

Common complications include infection, thrombosis, and stenosis, while serious complications may involve vascular injury or device failure.

What training is required for dialysis access devices?

Training typically involves hands-on experience in vascular access techniques, understanding device-specific features, and competency in managing potential complications.

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