# K972207: Medcomp Ash Split-Cath 28CM, Medcomp Ash Split-Cath 32CM

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp
- Decided: Feb 23, 1998 after 256 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
No predicates in its family tree.
49 later devices descend from it; 5 cite it directly.
4 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K020465: Medcomp Ash Split-Cath II (2002), 29 descendants of its own
- K994105: Hemo-Flow Double Lumen Catheter, Models HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 (2001), 20 descendants of its own
- K030502: 14.5F X 55CM Hemo-Flow Double Lumen Catheter, Models HFS-55, HFT-55 (2003), 13 descendants of its own
- K030020: Hemosplit Long-Term Hemodialysis Catheter (2003), 12 descendants of its own
- K022678: Medcomp SC4 (2003), 11 descendants of its own

## Indications for use
The Medcomp Ash Split-Cath™ Double Lumen Catheter is designed for chronic hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the jugular vein. Although this catheter may be mserted into the subclavian vein, the internal jugular is the preferred site

Source page: https://510kreport.com/device/K972207
Methodology: https://510kreport.com/methodology