# K130889: Split Cath RG

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp
- Decided: Apr 28, 2014 after 395 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: 4 generations back to K981994 (1998). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121848: Split Cath Iii 24CM Split Cath Iii 24CM Split Cath Iii 32CM Cath Iii 36CM Split Cath Iii 40CM and 55CM, Medical Components, Inc. (2012) Summary page 4.
- K022678: Medcomp SC4, Medcomp (2003) Summary page 4.

## Indications for use
The Medcomp Split Cath® Rg is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis in the adult patient. It may be inserted percutaneously and is primarily placed in the internal jugular vein, Alternate insertion sites include the subclavian vein and femoral vein.

Source page: https://510kreport.com/device/K130889
Methodology: https://510kreport.com/methodology