# K020315: 14F X 55CM Ash Split-Cath XL, Model ASPC55-XL

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp
- Decided: May 24, 2002 after 115 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have 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) Summary page 1.
- K012562: Medcomp 14.5F Double Lumen Hemodialysis Catheter, Medical Components, Inc. (2002). Cleared while this submission was under review Summary page 1.

## Indications for use
The Medcomp Ash Split-Cath XL is indicated for use in attaining 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 sites include the subclavian vein. Catheters greater than 40cm are intended for femoral vein insertion.

Source page: https://510kreport.com/device/K020315
Methodology: https://510kreport.com/methodology