# K051280: Medcomp Split Cath II

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp
- Decided: Nov 30, 2005 after 197 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: 3 generations back to K981994 (1998). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020465: Medcomp Ash Split-Cath II, Medcomp (2002) Summary page 1.
- K884375: Translumbar Aortography Needle Catheter, Argon Medical Corp. (1989) Summary page 1.

## Most influential descendants
- K111651: Split Cath Iii (2011), 0 descendants of its own

## Indications for use
THE MEDCOMP SPLIT CATH® II CATHETER 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 INFERIOR VENA CAVA AS REQUIRED. CATHETERS GREATER THAN 40CM ARE INTENDED FOR FEMORAL VEIN OR INFERIOR VENA CAVA INSERTION. TRANSLUMBAR INSERTION VIA INFERIOR VENA CAVA IS INDICATED WHEN ALL OTHER ACCESS SITES ARE IDENTIFIED AS NON-VIABLE.

Source page: https://510kreport.com/device/K051280
Methodology: https://510kreport.com/methodology