# K200627: GlidePath 10F Long-Term Dialysis Catheter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jun 22, 2020 after 104 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: 7 generations back to K981994 (1998). 12 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190527: GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters, C. R. Bard (2020) Summary page 4.
- K020936: 10F X 18CM Pediatric Ash Split Cath XL, Model ASPC18P-XL; 10F X 24CM Pediatric Ash Split-Cath XL, Model ASPC24P-XL, Medcomp (2002) Summary page 4.

## Most influential descendants
- K202150: GlidePath 7.5F Long-Term Dialysis Catheter (2020), 1 descendant of its own
- K241581: Hemodialysis Catheter (2025), 0 descendants of its own

## Indications for use
The GlidePath™ 10F long-term hemodialysis catheter is indicated for use in attaining short-term or long-term vascular access in pediatric, adolescent and adult patients for hemodialysis, hemoperfusion or apheresis as determined by the prescribing physician. Access is attained via the internal jugular vein, subclavian vein, or femoral vein. Catheters longer than 22 cm are intended for femoral vein insertion, depending on patient anatomy and size.

Source page: https://510kreport.com/device/K200627
Methodology: https://510kreport.com/methodology