# K022678: Medcomp SC4

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp
- Decided: Feb 24, 2003 after 196 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.
11 later devices descend from it; 2 cite it directly.
3 of 17 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)
- K971925: Medcomp Bio-Flex CS Catheter (CS100), Medical Components, Inc. (1998) Summary page 1.

## Most influential descendants
- K040318: Medcomp Split-Cath II (2005), 9 descendants of its own
- K070572: Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM (2007), 7 descendants of its own
- K080400: Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure Kit (2008), 6 descendants of its own
- K101843: Duramax Chronic Hemodialysis Catheter and Procedure Kit (2010), 2 descendants of its own
- K092597: Centros Chronic Hemodialysis Catheter Set (2009), 2 descendants of its own

## Indications for use
THE MEDCOMP SC4 HEMODIALYSIS CATHETER IS INDICATED FOR USE IN ATTAINING LONG-TERM VASCULAR ACCESS FOR HEMODIALYSIS AND APHERESIS. IT MAY BE INSERTED PERCUTANEOUSLY AND IS PRIMARILY PLACED IN THE INTERNAL JUGULAR VEIN. ALTERNATE INSERTION SITES INCLUDE THE SUBCLAVIAN VEIN. CATHETERS GREATER THAN 40CM ARE INTENDED FOR FEMORAL VEIN INSERTION. THE SC4 EXTENSION SET IS INTENDED TO REPAIR THE SC4 HEMODIALYSIS CATHETER.

Source page: https://510kreport.com/device/K022678
Methodology: https://510kreport.com/methodology