Dialysis Access Devices

85 devices 23 with evidence

Clinical Overview

Devices for hemodialysis access creation and maintenance.

Procedures that use dialysis access

Fistulogram with Angioplasty

Dialysis Access Devices by manufacturer

6 product lines from 4 manufacturers registered with the FDA. Sizes are as listed in the FDA device identification database; confirm with the manufacturer's instructions for use.

Manufacturer	Product	Sizes (FDA GUDID)	Models	MRI
W. L. Gore & Associates, Inc.	GORE VIABAHN Endoprosthesis with Heparin VIABAHN SX ENDO HEPARIN 35 5mmX5cm 7Fr 120cmCath FDA record Suggest edits	Length: 2.5–25 cm; Lumen/Inner Diameter: 5–13 mm; Catheter Gauge: 8–11 Fr	150	MR Conditional
Angiomed GmbH & Co. Medizintechnik KG	Covera COVERA™ Vascular Covered Stent 9 mm x 40 mm (120 cm delivery catheter) (straight) Suggest edits	—	90	MR Conditional
W. L. Gore & Associates, Inc.	GORE VIABAHN Endoprosthesis VIABAHN SX ENDO 35 RO 7mmX2.5cm 8Fr 120cmCath FDA record Suggest edits	Length: 2.5–15 cm; Lumen/Inner Diameter: 2.5–13 mm; Catheter Gauge: 7–10 Fr	86	MR Conditional
Bard Peripheral Vascular, Inc.	Fluency Endovascular Stent Graft FLUENCY® PLUS Endovascular Stent Graft 6 mm x 60 mm (80 cm delivery system) Suggest edits	—	70	MR Conditional
Bard Peripheral Vascular, Inc.	Flair Endovascular Stent Graft FLAIR® Endovascular Stent Graft 6 mm x 70 mm (80 cm delivery catheter)(flared) Suggest edits	—	30	MR Conditional
Merit Medical Systems, Inc.	Wrapsody Suggest edits	—	1	Not stated

All Manufacturers Ameco Medical Industries Angiodynamics Argon Medical Arrow Int'L. Arrow International Arrow International, Inc. (Subsidiary Of Teleflex, Inc.) Ash Access Technology B. Braun Medical Bard Access Systems Bard Peripheral Vascular Bd Becton Dickinson Vacutainer Systems Preanalytic C B Bard C. R. Bard C.R. Bard Cook Covidien Lp, Formerly Registered As Kendall Deseret Medical Diasol Dimesol Haolang Medical U Health Line International Itl Corporation Pty Jms Kendall Marvao Medical Devices Medcomp (Dba Medical Components, Inc.) Medical Components Medical Components, Inc. (Dba Medcomp) Merit Medical Systems Phase One Medical Pristine Access Technologies Rex Medical Spire Biomedical Tayside Flow Technologies Teleflexmedical Terumo America Terumo Medical Tyco Healthcare Group Vascular Flow Technologies All Pathways 510K Any Evidence Level 1+ Studies 2+ Studies 5+ Studies 10+ Studies Filter Clear Filters

Device	Manufacturer	Pathway	Cleared	Evidence
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
Shelly Protected AV Fistula Needle Other clearances: 1999	Diasol	510(k)	1999	—
Step-Tip Chronic Hemodialysis Catheter Evidence	Arrow International	510(k)	2004	—
15 5f Hemo-Stream Hemodialysis Catheter Set Evidence	Rex Medical	510(k)	2007	—
AngioDynamics Inc More-Flow Hemodialysis Catheter and Procedure Kit	Angiodynamics	510(k)	2004	—
Hemo-Stream Hemodialysis Catheter Set Evidence	Rex Medical	510(k)	2003	—
Spiral Laminar Flow Vascular Arteriovenous Graft AV0645 Evidence	Vascular Flow Technologies	510(k)	2025	—
Jms AV Fistula Needle	Jms	510(k)	1986	—
Nexsite HD Hemodialysis Catheter for Long Term Use 28cm Nexsite HD Hemodialysis Catheter for Long Term Use 24cm Evidence	Marvao Medical Devices	510(k)	2013	—
AngioDynamics Inc Duramax Hemodialysis Catheter and Procedure Kit Evidence	Angiodynamics	510(k)	2008	—
Centros Long-Term Hemodialysis Catheter Centrosflo Long-Term Hemodialysis Catheter Other clearances: 2014	Merit Medical Systems	510(k)	2016	—
Acute Dual Lumen Hemodialysis Catheter Evidence	Health Line International	510(k)	2020	—
Medcomp 14 5f Double Lumen Hemodialysis Catheter	Medical Components	510(k)	2002	—
Pristine Long-Term Hemodialysis Catheter	C B Bard	510(k)	2021	—
Glidepath Long-Term Hemodialysis Catheters Hemostar Long-Term Hemodialysis Catheters Hemostar Xk Long-Term Hemodialysis Catheters	C. R. Bard	510(k)	2020	—
Pallindrome 14 5Fr Chronic Hemodialysis Catheter with Slotted Symmetrical Tip	Kendall	510(k)	2004	—
Pallindrome 14 5Fr Chronic Hemodialysis Catheter	Kendall	510(k)	2004	—
Ash Advance Hemodialysis Catheter and Procedure Kit Models 15Fr x 24cm 15Fr x 28cm 15Fr x 32cm Evidence	Ash Access Technology	510(k)	2007	—
Decathlon Twin Lumen Hemodialysis Catheter with Separated TIPS Models DE19SH24 DE23SH28 DE27SH32 DE31SH36 DE35SH40	Spire Biomedical	510(k)	2008	—
Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated TIPS with and Without Side Holes	Spire Biomedical	510(k)	2002	—
Power Acute Triple Lumen Hemodialysis Catheter	Health Line International	510(k)	2023	—
15 5 Fr Decathlon Gold Funnel TIPS Coated Hemodialysis Catheter DFC19SH24 DFC23SH28 DFC27SH32 DFC31SH36 DFC35SH40	Spire Biomedical	510(k)	2007	—
Nexsite HD 55cm Hemodialysis Catheter for Long Term Use	Marvao Medical Devices	510(k)	2014	—
Spiral Flow Vascular Arteriovenous Graft Evidence	Vascular Flow Technologies	510(k)	2014	—
Hemoglide Series and Hemoglide Star Series Xk Long-Term Hemodialysis Catheters Evidence	C.R. Bard	510(k)	2005	—
Symetrex Long Term Hemodialysis Catheter	Medcomp (Dba Medical Components, Inc.)	510(k)	2017	—
Hemodialysis Catheter Evidence	Haolang Medical U	510(k)	2025	—
Platypus AV Fistula Needle Protector Avfnp	Itl Corporation Pty	510(k)	1999	—
AV Fistula Needle Set Evidence	Terumo America	510(k)	1977	—
Cook Turbo-Flo HD Acute Hemodialysis Catheter Set Tray Cook Spectrum Turbo-Flo HD Acute Hemodialysis Catheter Set Tray Evidence	Cook	510(k)	2013	—
14 5 Fr Chronic Hemodialysis Catheter with Insertion Stylets Accessory Evidence	Kendall	510(k)	2005	—
Cook Turbo-Flo HD Acute Hemodialysis Catheter Set Tray Evidence	Cook	510(k)	2017	—
Nextstep Antegrade Chronic Hemodialysis Catheter	Teleflexmedical	510(k)	2011	—
Duramax Chronic Hemodialysis Catheter and Procedure Kit Evidence	Angiodynamics	510(k)	2010	—
Duet Long-Term Hemodialysis Catheter System Duet Long-Term Hemodialysis Catheter System Catheter Repair Kit	C.R. Bard	510(k)	2009	—
Tandem-Cath Hemodialysis Catheter Model 10 Fr Evidence	Kendall	510(k)	2004	—
Dimesol Disposable AV Fistula Needle Set Non-Safety Series and Dimesol Disposable AV Fistula Needle Set Safety Series	Dimesol	510(k)	2018	—
Pourchez Xpresso Twin Limen Chronic Hemodialysis Catheter	Spire Biomedical	510(k)	2002	—
Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions Evidence	Arrow International, Inc. (Subsidiary Of Teleflex, Inc.)	510(k)	2015	—
Ultrastream Chronic Hemodialysis Catheter Evidence	Rex Medical	510(k)	2010	—
Uldall Double Lumen Hemodialysis Catheter Set Tray Evidence	Cook	510(k)	1994	—
Arrow R Nextstep Tm Antegrade Chronic Hemodialysis Catheter	Teleflexmedical	510(k)	2011	—
Long-Term Hemodialysis Catheters with Biobloc Coating	Bard Access Systems	510(k)	2006	—
24cm Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated TIPS	Spire Biomedical	510(k)	2002	—