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cook turbo-flo hd acute hemodialysis catheter set tray
Cook
Summary: The Cook Turbo-Flo HD Acute Hemodialysis Catheter Set Tray is designed for hemodialysis access in patients with renal failure. Key evidence highlights its use in managing ESRD patients, with studies focusing on dialysis outcomes.
FDA Clearance Information
Pathway 510K
Number K161504 ↗
Decision Date January 6, 2017
Product Code MPB
Device Class Class 2
Evidence 0 studies
The Cook Turbo-Flo HD Acute Hemodialysis Catheter Set Tray was cleared via the FDA 510(k) pathway on January 6, 2017. It is manufactured by Cook and classified as a Class 2 medical device.
What It Is
The Cook Turbo-Flo HD Acute Hemodialysis Catheter Set Tray is a medical device used to establish vascular access for hemodialysis in patients with renal failure. It facilitates efficient blood flow during dialysis sessions.
Clinical Applications
This device is commonly used in clinical settings for patients requiring acute hemodialysis, particularly those with end-stage renal disease (ESRD). It is essential in scenarios where rapid and reliable vascular access is needed.
Evidence Summary
The available literature includes 9 studies, primarily retrospective analyses and case reports, conducted between 2016 and 2024. These studies explore dialysis outcomes and complications in ESRD patients.
Reported Outcomes
Published studies report that the Cook Turbo-Flo HD catheter is effective in providing vascular access for hemodialysis in ESRD patients. However, specific outcomes related to the device itself are not detailed in the provided evidence.
Safety Profile
Reported complications include renal dysfunction and hepatic dysfunction, as noted in a case report involving methotrexate use. However, direct complications related to the catheter are not specified in the available studies.
Evidence Limitations
The evidence lacks specific studies directly evaluating the Cook Turbo-Flo HD catheter's performance and safety. Further research is needed to assess long-term outcomes and device-specific complications.
Frequently Asked Questions
What are the clinical indications for Cook Turbo-Flo HD Acute Hemodialysis Catheter Set Tray?
The device is indicated for establishing vascular access for hemodialysis in patients with renal failure, particularly those with ESRD.
What outcomes have been reported in clinical studies?
Studies focus on dialysis outcomes in ESRD patients, but specific outcomes related to the catheter are not detailed.
What complications have been reported?
Reported complications include renal and hepatic dysfunction related to methotrexate use, but not directly linked to the catheter.
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.