# K030020: Hemosplit Long-Term Hemodialysis Catheter

- Pathway: 510(k) (Abbreviated)
- Applicant: C.R. Bard, Inc.
- Decided: Jun 16, 2003 after 164 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.
12 later devices descend from it; 4 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010567: Optiflow Catheter #5641190 Catheter Only #5643150 Catheter Kit #5631000 Catheterless Tray-Generic (Combined with Cathetr, C.R. Bard, Inc. (2001)
- K020465: Medcomp Ash Split-Cath II, Medcomp (2002) Summary page 1.

## Most influential descendants
- K033294: Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM, Kit with Microintroducer (2003), 10 descendants of its own
- K051748: Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis Catheters (2005), 8 descendants of its own
- K190527: GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters (2020), 5 descendants of its own
- K200627: GlidePath 10F Long-Term Dialysis Catheter (2020), 2 descendants of its own
- K202150: GlidePath 7.5F Long-Term Dialysis Catheter (2020), 1 descendant of its own

## Indications for use
The HemoSplit long-term hemodialysis catheter is indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein, or femoral vein. Catheters greater than 40 cm are intended for femoral vein insertion.

Source page: https://510kreport.com/device/K030020
Methodology: https://510kreport.com/methodology