# K040992: 15F X 55CM Excell Split -Tip Catheter, Models 10300606, 10300706

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp
- Decided: Jul 29, 2004 after 104 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: 3 generations back to K972207 (1998). 6 ancestors in all.
8 later devices descend from it; 1 cites it directly.
3 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010306: Medcomp Excell Split Tip Catheter, Medcomp (2001) Summary page 1.
- K012562: Medcomp 14.5F Double Lumen Hemodialysis Catheter, Medical Components, Inc. (2002) Summary page 1.
- K030502: 14.5F X 55CM Hemo-Flow Double Lumen Catheter, Models HFS-55, HFT-55, 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 EXCELLTM SPLIT-TIP 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. ALTERNATE INSERTION SITES INCLUDE THE SUBCLAVIAN VEIN AS REQUIRED. CATHETERS GREATER THAN 40CM ARE INTENDED FOR FEMORAL VEIN INSERTION.

Source page: https://510kreport.com/device/K040992
Methodology: https://510kreport.com/methodology