# K101843: Duramax Chronic Hemodialysis Catheter and Procedure Kit - Pathway: 510(k) (Traditional) - Applicant: AngioDynamics, Inc. - Decided: Oct 20, 2010 after 111 days - Product code: MSD (Catheter, Hemodialysis, Implanted) - Device class: 2 - Regulation: 21 CFR 876.5540 - Recalls of this device: 30 (1 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 7 generations back to K981994 (1998). 15 ancestors in all. 2 later devices descend from it; 2 cite it directly. 2 of 18 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K080400: Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure Kit, AngioDynamics, Inc. (2008) Summary page 1. - K040402: Angiodynamics, Inc. More-Flow Hemodialysis Catheter and Procedure Kit, AngioDynamics, Inc. (2004) Summary page 1. ## Most influential descendants - K131260: Nmi Dialysis Catheter (2014), 0 descendants of its own - K110936: Duraflow 2 Chronic Hemodialysis Catheter and Procedure Kit (2011), 0 descendants of its own ## Recalls of this device - Feb 13, 2026 · Class I · Z-1578-2026: 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired cathe - Mar 18, 2024 · Class II · Z-1771-2024: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. - Mar 18, 2024 · Class II · Z-1772-2024: XXX - Mar 18, 2024 · Class II · Z-1766-2024: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. - Mar 18, 2024 · Class II · Z-1767-2024: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. - Mar 18, 2024 · Class II · Z-1768-2024: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. - Mar 18, 2024 · Class II · Z-1769-2024: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. - Mar 18, 2024 · Class II · Z-1773-2024: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. - Mar 18, 2024 · Class II · Z-1770-2024: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. - Dec 30, 2011 · Not classified · Z-0719-2012: The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. - Dec 30, 2011 · Not classified · Z-0720-2012: The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. - Dec 30, 2011 · Not classified · Z-0721-2012: The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. - Dec 30, 2011 · Not classified · Z-0724-2012: The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. - Dec 30, 2011 · Not classified · Z-0725-2012: The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. - Dec 30, 2011 · Not classified · Z-0726-2012: The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. - Dec 30, 2011 · Not classified · Z-0729-2012: The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. - Dec 30, 2011 · Not classified · Z-0730-2012: The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. - Dec 30, 2011 · Not classified · Z-0731-2012: The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. - Dec 30, 2011 · Not classified · Z-0732-2012: The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. - Dec 30, 2011 · Not classified · Z-0718-2012: The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. - Dec 30, 2011 · Not classified · Z-0722-2012: The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. - Dec 30, 2011 · Not classified · Z-0723-2012: The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. - Dec 30, 2011 · Not classified · Z-0727-2012: The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. - Dec 30, 2011 · Not classified · Z-0728-2012: The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. - Dec 30, 2011 · Not classified · Z-0733-2012: The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. - Jan 24, 2011 · Not classified · Z-0588-2012: AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use. - Jan 24, 2011 · Not classified · Z-0589-2012: AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use. - Jan 24, 2011 · Not classified · Z-0586-2012: AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use. - Jan 24, 2011 · Not classified · Z-0590-2012: AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use. - Jan 24, 2011 · Not classified · Z-0587-2012: AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use. ## Indications for use The AngioDynamics, Inc. Duralvax~i Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternative insertion sites include the subclavian vein as required. Catheters greater than 40cm are intended for femoral vein insertion. This catheter is indicated for > 30 days long-term placement. Source page: https://510kreport.com/device/K101843 Methodology: https://510kreport.com/methodology