# K051748: Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis Catheters

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Aug 12, 2005 after 44 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K981994 (1998). 7 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 16 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.
- K033294: Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM, Kit with Microintroducer, C.R. Bard, Inc. (2003) Summary page 1.

## Most influential descendants
- 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
- K241581: Hemodialysis Catheter (2025), 0 descendants of its own

## Recalls of this device
- May 31, 2019 · Class II · Z-2388-2019: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
- May 31, 2019 · Class II · Z-2390-2019: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
- May 31, 2019 · Class II · Z-2386-2019: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
- May 31, 2019 · Class II · Z-2387-2019: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
- May 31, 2019 · Class II · Z-2385-2019: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
- May 31, 2019 · Class II · Z-2392-2019: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
- May 31, 2019 · Class II · Z-2393-2019: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
- May 31, 2019 · Class II · Z-2384-2019: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
- May 31, 2019 · Class II · Z-2395-2019: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
- May 31, 2019 · Class II · Z-2391-2019: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
- May 31, 2019 · Class II · Z-2394-2019: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
- May 31, 2019 · Class II · Z-2383-2019: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
- May 31, 2019 · Class II · Z-2389-2019: The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.

## Indications for use
The HemoGlide® Star series and HemoGlide® Star series 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, 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/K051748
Methodology: https://510kreport.com/methodology