# K190527: GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters

- Pathway: 510(k) (Traditional)
- Applicant: C. R. Bard
- Decided: Mar 5, 2020 after 367 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: 6 generations back to K981994 (1998). 8 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051748: Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis Catheters, C.R. Bard, Inc. (2005) Summary page 4.

## Most influential descendants
- 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
- K241581: Hemodialysis Catheter (2025), 0 descendants of its own
- K203575: GlidePath Retro Long-Term Hemodialysis Catheter (2021), 0 descendants of its own
- K211410: GlidePath 13F Long-Term Hemodialysis Catheter (2021), 0 descendants of its own

## Indications for use
The GlidePath™ Long-Term Hemodialysis Catheters are 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, subclavian vein, or femoral vein. Catheters longer than 40cm are intended for femoral vein insertion. The HemoStar™ and HemoStar™ XK Long-Term Hemodialysis Catheters are 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, subclavian vein or femoral vein. Catheters greater than 40 cm are intended for femoral vein insertion.

Source page: https://510kreport.com/device/K190527
Methodology: https://510kreport.com/methodology