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Cook Turbo-Flo HD Acute Hemodialysis Catheter Set Tray Cook Spectrum Turbo-Flo HD Acute Hemodialysis Catheter Set Tray
Summary: The Cook Turbo-Flo HD Acute Hemodialysis Catheter Set Tray is a medical device designed for acute hemodialysis. It is FDA 510k cleared and is supported by evidence from 9 studies, focusing on its clinical applications and safety profile.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K122091 ↗
Decision Date ?
July 29, 2013
Product Code ?
MPB Catheter, Hemodialysis, Non-Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The Cook Turbo-Flo HD Acute Hemodialysis Catheter Set Tray was cleared by the FDA via the 510k pathway on July 29, 2013. It is manufactured by Cook and classified as a Class 2 device.
What It Is
The Cook Turbo-Flo HD Acute Hemodialysis Catheter Set Tray is a catheter system designed for acute hemodialysis. It facilitates efficient blood flow during dialysis sessions, intended for use in patients requiring temporary vascular access.
FDA-Cleared Indications
- Provides temporary vascular access for hemodialysis.
- Used for acute hemodialysis when short-term extracorporeal blood access is required.
- The catheter is intended for non-implanted use.
Clinical Applications
- Temporary hemodialysis access in patients with acute kidney injury.
- Hemodialysis when an arteriovenous fistula or graft is not available or cannot be used.
- Urgent dialysis requiring placement of a central venous dialysis catheter.
- Use during short-term inpatient or critical-care dialysis treatment.
Evidence Summary
The available literature includes 9 studies, encompassing various types of research such as case reports and retrospective analyses. The studies span from 2016 to 2024, providing insights into the device's clinical outcomes and safety.
Reported Outcomes
Published studies report mixed outcomes regarding the efficacy of hemodialysis in patients with specific conditions, such as end-stage renal disease and acute myocardial infarction. However, direct evidence specific to the Cook Turbo-Flo HD device is limited in the provided studies.
Safety Profile
Reported complications include renal dysfunction and hepatic dysfunction, as noted in a case report involving methotrexate. However, specific safety data directly related to the Cook Turbo-Flo HD device is not detailed in the provided evidence.
Evidence Limitations
The evidence provided lacks direct studies on the Cook Turbo-Flo HD device, focusing instead on broader hemodialysis outcomes. Further research is needed to evaluate specific device-related outcomes and safety in diverse patient populations.
Practical Considerations
- Placement generally requires central venous access, commonly through the internal jugular or femoral vein; the subclavian vein may be used selectively because of stenosis risk.
- Ultrasound and fluoroscopic or other imaging guidance may be used to place and confirm the catheter position.
- The catheter size, length, lumen configuration, and included components should be selected according to the patient, access site, prescribed blood-flow rate, and dialysis system.
- Follow the product instructions for catheter flushing, locking, dressing changes, connection to dialysis equipment, and removal.
- MRI conditions, if applicable, must be confirmed in the current product labeling; do not assume the catheter or tray is MRI safe without manufacturer documentation.
Frequently Asked Questions
What are the clinical indications for Cook Turbo-Flo HD Acute Hemodialysis Catheter Set Tray?
The device is indicated for use in acute hemodialysis, providing temporary vascular access for patients with acute kidney failure.
What outcomes have been reported in clinical studies?
The studies report outcomes related to hemodialysis efficacy in various conditions, but specific outcomes for the Cook Turbo-Flo HD device are not detailed.
What complications have been reported?
Reported complications include renal and hepatic dysfunction in the context of methotrexate use, but specific device-related complications are not provided.
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.