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Hemoglide Series and Hemoglide Star Series Xk Long-Term Hemodialysis Catheters
Summary: The Hemoglide series by C.R. Bard are long-term hemodialysis catheters. They are primarily used for vascular access in dialysis patients. Key evidence findings are not available from the provided studies.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K051748 ↗
Decision Date ?
August 12, 2005
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The Hemoglide series catheters were cleared by the FDA via the 510(k) pathway on August 12, 2005. They are manufactured by C.R. Bard and classified as Class 2 devices under product code MSD.
What It Is
The Hemoglide series are hemodialysis catheters designed for long-term vascular access in patients requiring dialysis. These devices facilitate efficient blood flow and are intended for use in clinical settings where long-term dialysis access is necessary.
FDA-Cleared Indications
- Long-term vascular access for hemodialysis.
- Use in patients who require hemodialysis through an implanted hemodialysis catheter.
Clinical Applications
- Providing temporary-to-long-term central venous access for repeated hemodialysis treatments.
- Connecting a patient to a hemodialysis machine for extracorporeal blood removal and return.
- Use when an arteriovenous fistula or graft is unavailable, not yet mature, or cannot be used.
Evidence Summary
The available literature includes 9 studies, though none directly address the Hemoglide series. The studies range from 2021 to 2024 and cover various unrelated topics, indicating a lack of specific evidence for these devices.
Reported Outcomes
Published studies report no specific efficacy findings related to the Hemoglide series catheters. The evidence provided does not include direct outcomes from clinical use of these devices.
Safety Profile
Reported complications include no specific safety data related to the Hemoglide series catheters. The provided studies do not offer insights into adverse events or complications associated with these devices.
Evidence Limitations
There is a significant gap in direct evidence regarding the Hemoglide series catheters. The studies provided do not focus on these devices, highlighting a need for targeted research to evaluate their clinical efficacy and safety.
Practical Considerations
- Placement is generally performed through a central vein, commonly the internal jugular vein, with the catheter tunneled under the skin before exiting the chest.
- Catheter length and configuration must match the patient's anatomy and intended tip position; the specific available sizes depend on the cleared model and product labeling.
- Placement and function are typically assessed with ultrasound and fluoroscopy or other appropriate imaging guidance.
- Important risks include infection, thrombosis, catheter malfunction, bleeding, vessel injury, and malposition. Catheter care and sterile access technique are essential.
- MRI safety and conditions depend on the exact model and labeling; confirm the device-specific MRI status before scanning. These catheters are not a substitute for an arteriovenous fistula or graft when those options are appropriate.
Frequently Asked Questions
What are the clinical indications for hemoglide catheters?
The Hemoglide series catheters are indicated for long-term vascular access in patients requiring hemodialysis.
What outcomes have been reported in clinical studies?
Specific findings from evidence are not available for the Hemoglide series catheters in the provided studies.
What complications have been reported?
Safety data from evidence is not available for the Hemoglide series catheters in the provided studies.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.