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cook turbo-flo hd acute hemodialysis catheter set tray cook spectrum turbo-flo hd acute hemodialysis catheter set tray
Cook
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
510K
Number
K122091 ↗
Decision Date
July 29, 2013
Product Code
MPB
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.
Clinical Applications
This device is commonly used in clinical settings for patients with acute kidney failure requiring immediate hemodialysis. It is particularly useful in emergency situations where rapid vascular access is necessary.
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.
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.