# K020465: Medcomp Ash Split-Cath II

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp
- Decided: May 22, 2002 after 99 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: 2 generations back to K981994 (1998). 3 ancestors in all.
29 later devices descend from it; 6 cite it directly.
3 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972207: Medcomp Ash Split-Cath 28CM, Medcomp Ash Split-Cath 32CM, Medcomp (1998) Summary page 1.
- K012562: Medcomp 14.5F Double Lumen Hemodialysis Catheter, Medical Components, Inc. (2002) Summary page 1.

## Most influential descendants
- K030020: Hemosplit Long-Term Hemodialysis Catheter (2003), 12 descendants of its own
- K022678: Medcomp SC4 (2003), 11 descendants of its own
- K033294: Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM, Kit with Microintroducer (2003), 10 descendants of its own
- K040318: Medcomp Split-Cath II (2005), 9 descendants of its own
- K051748: Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis Catheters (2005), 8 descendants of its own

## Indications for use
THE MEDCOMP ASH SPLIT-CATH Ii 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/K020465
Methodology: https://510kreport.com/methodology