# K033294: Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM, Kit with Microintroducer

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Nov 26, 2003 after 43 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). 6 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030020: Hemosplit Long-Term Hemodialysis Catheter, C.R. Bard, Inc. (2003) Summary page 1.

## Most influential descendants
- 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
- K053589: Long-Term Hemodialysis Catheters with Biobloc Coating (2006), 1 descendant of its own

## Indications for use
The Hernosplit 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/K033294
Methodology: https://510kreport.com/methodology