# K070572: Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM

- Pathway: 510(k) (Traditional)
- Applicant: Ash Access Technology, Inc.
- Decided: Jun 26, 2007 after 118 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K981994 (1998). 13 ancestors in all.
7 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)
- K002901: Kendall 14.5 FR Maxid Cuffed Dual Lumen Catheter, The Kendall Company (2001) Summary page 1.
- K040318: Medcomp Split-Cath II, Medcomp (2005) Summary page 1.
- K040402: Angiodynamics, Inc. More-Flow Hemodialysis Catheter and Procedure Kit, AngioDynamics, Inc. (2004) Summary page 1.
- K040992: 15F X 55CM Excell Split -Tip Catheter, Models 10300606, 10300706, Medcomp (2004) Summary page 1.

## Most influential descendants
- K080400: Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure Kit (2008), 6 descendants of its own
- 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

## Recalls of this device
- Jul 7, 2008 · Not classified · Z-2397-2008: The cuff may be inadequately attached to the catheter, resulting in possible catheter movement or leakage at the insertion site.
- Jul 7, 2008 · Not classified · Z-2398-2008: The cuff may be inadequately attached to the catheter, resulting in possible catheter movement or leakage at the insertion site.
- Jul 7, 2008 · Not classified · Z-2396-2008: The cuff may be inadequately attached to the catheter, resulting in possible catheter movement or leakage at the insertion site.

## Indications for use
The Ash AdvanceTM Hemodialysis Catheter and Procedure Kit 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. This catheter is indicated for > 30 days long-term placement.

Source page: https://510kreport.com/device/K070572
Methodology: https://510kreport.com/methodology