# K020936: 10F X 18CM Pediatric Ash Split Cath XL, Model ASPC18P-XL; 10F X 24CM Pediatric Ash Split-Cath XL, Model ASPC24P-XL

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp
- Decided: Oct 11, 2002 after 203 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 K972207 (1998). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013162: 14F X 24CM Ash Split-Cath,14F X 28CM Ash Split-Cath, 14F X 32CM Ash Split-Cath, 14FX36CM Ash Split-Cath, 14F X 40CM Ash, Medcomp (2001)
- K984022: Pediatric Two-Lumen Hemodialysis Catherization Kit, Arrow Intl., Inc. (1999) Summary page 1.

## Most influential descendants
- K200627: GlidePath 10F Long-Term Dialysis Catheter (2020), 2 descendants of its own
- K202150: GlidePath 7.5F Long-Term Dialysis Catheter (2020), 1 descendant of its own
- K241581: Hemodialysis Catheter (2025), 0 descendants of its own

## Indications for use
The Medcomp Pediatric Ash Split CathTMXL is indicated for use in attaining long-term vascular access for hemodialysis and apheresis in pediatric, adolescent, and adult patients as determined by the prescribing physician. It may be inserted percutaneously and is primarily placed in the internal jugular vein. Alternate insertion sites include the subclavian and femoral vein.

Source page: https://510kreport.com/device/K020936
Methodology: https://510kreport.com/methodology