# K080400: Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure Kit

- Pathway: 510(k) (Traditional)
- Applicant: AngioDynamics, Inc.
- Decided: May 13, 2008 after 90 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K981994 (1998). 14 ancestors in all.
6 later devices descend from it; 2 cite it directly.
3 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070572: Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM, Ash Access Technology, Inc. (2007) Summary page 2.
- K994105: Hemo-Flow Double Lumen Catheter, Models HFS-24, HFS-28, HFS-32, HFS-36, HFS-40, Medical Components, Inc. (2001) Summary page 2.
- K030502: 14.5F X 55CM Hemo-Flow Double Lumen Catheter, Models HFS-55, HFT-55, Medcomp (2003) Summary page 2.

## Most influential descendants
- K101843: Duramax Chronic Hemodialysis Catheter and Procedure Kit (2010), 2 descendants of its own
- K092597: Centros Chronic Hemodialysis Catheter Set (2009), 2 descendants of its own
- K141363: Centros Long Term Hemodialysis Catheter, Centrosflo Long Term Hemodialysis Catheter (2014), 1 descendant of its own
- K151967: Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter (2016), 0 descendants of its own
- K131260: Nmi Dialysis Catheter (2014), 0 descendants of its own

## Recalls of this device
- 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. DuraMaxTM 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/K080400
Methodology: https://510kreport.com/methodology