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15 5f Hemo-Stream Hemodialysis Catheter Set
Summary: The 15 5f Hemo-Stream Hemodialysis Catheter Set by Rex Medical is a device used for hemodialysis access. It is FDA 510k cleared and primarily used in dialysis settings. Key evidence includes studies on catheter placement and safety.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K071422 ↗
Decision Date ?
August 22, 2007
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510k pathway on August 22, 2007. It is manufactured by Rex Medical and classified as a Class 2 device under product code MSD.
What It Is
The 15 5f Hemo-Stream Hemodialysis Catheter Set is designed for vascular access in hemodialysis. It facilitates the removal and return of blood during dialysis sessions, providing a reliable means for extracorporeal blood circulation.
FDA-Cleared Indications
- Vascular access for hemodialysis.
- Access to the central venous circulation for withdrawal and return of blood during dialysis treatment.
Clinical Applications
- Placement of temporary central venous access for hemodialysis.
- Hemodialysis access when peripheral vascular access is inadequate or unavailable.
- Blood withdrawal and return during extracorporeal hemodialysis.
Evidence Summary
The available literature includes a mix of study types such as RCTs, prospective, and case series, with a total of 4 studies ranging from 1998 to 2007. These studies explore various aspects of catheter use and safety.
Reported Outcomes
Published studies report successful placement of tunneled central venous access catheters in the inferior vena cava with no immediate complications. The mean duration of catheter placement was reported to be 3 months, indicating effective long-term use.
Safety Profile
Reported complications include a moderate complication rate associated with direct translumbar catheterization of the IVC. However, this method is considered safe and effective for long-term catheter placement.
Evidence Limitations
The evidence is limited by the small number of studies and the variability in study design. Further research is needed to explore long-term outcomes and potential complications in diverse patient populations.
Practical Considerations
- The device is identified as a 5 French catheter set; the exact catheter configuration, length, lumens and flow specifications should be confirmed in the current manufacturer labeling.
- Placement generally requires sterile technique and imaging guidance, such as ultrasound and fluoroscopy, depending on the access site and clinical setting.
- Common central venous access sites may include the internal jugular, subclavian or femoral vein, selected according to the patient's anatomy and dialysis needs.
- MRI safety and conditions should be verified in the current device labeling; do not assume the catheter is MR Safe or MR Conditional without confirmation.
- Potential complications include bleeding, infection, thrombosis, malposition, vessel injury, air embolism and catheter dysfunction. Contraindications and precautions should be reviewed before placement.
Frequently Asked Questions
What are the clinical indications for 15 5f Hemo-Stream Hemodialysis Catheter Set?
The device is indicated for use in hemodialysis to provide vascular access for renal replacement therapy.
What outcomes have been reported in clinical studies?
Studies report successful catheter placement with no immediate complications and a mean duration of use of 3 months.
What complications have been reported?
Reported complications include a moderate complication rate with translumbar catheterization, though it is generally considered safe.
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.