# K040318: Medcomp Split-Cath II

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp
- Decided: Feb 3, 2005 after 360 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K981994 (1998). 6 ancestors in all.
9 later devices descend from it; 2 cite it directly.
3 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020465: Medcomp Ash Split-Cath II, Medcomp (2002) Summary page 1.
- K971925: Medcomp Bio-Flex CS Catheter (CS100), Medical Components, Inc. (1998) Summary page 1.
- K022678: Medcomp SC4, Medcomp (2003) Summary page 1.

## Most influential descendants
- K070572: Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM (2007), 7 descendants of its own
- 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

## Indications for use
The Medcomp® Split-Cath® II is indicated for use in attaining chronic (long-term) vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein of an adult patient. Alternate insertion site includes the subclavian vein as required.

Source page: https://510kreport.com/device/K040318
Methodology: https://510kreport.com/methodology