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central venous access catheter
Hemed
Summary: The central venous access catheter by Hemed is a device used for venous access in various clinical settings. Key evidence highlights surgical experience as a factor in pediatric outcomes and the role of imaging in placement accuracy.
FDA Clearance Information
Pathway
510K
Number
K820736 ↗
Decision Date
April 15, 1982
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The central venous access catheter by Hemed was cleared through the FDA 510(k) pathway on April 15, 1982. It is classified as a Class 2 device under product code DQY.
What It Is
The central venous access catheter is a medical device designed to provide venous access for the administration of medications, fluids, and for blood sampling. It is commonly used in patients requiring long-term intravenous therapy.
Clinical Applications
This device is frequently used in scenarios such as chemotherapy administration, parenteral nutrition, and in patients with difficult venous access. It is also utilized in critical care settings for hemodynamic monitoring.
Evidence Summary
The literature includes 15 studies, encompassing retrospective and prospective designs, with publication dates ranging from 2004 to 2023. These studies explore various aspects of catheter use, including surgical techniques and imaging guidance.
Reported Outcomes
Published studies report that surgical experience significantly affects outcomes in pediatric catheter implantation. Imaging techniques, such as ultrasound and fluoroscopy, are crucial for accurate placement and reducing complications. The use of tissue plasminogen activator has been shown to reduce infection rates in some cases.
Safety Profile
Reported complications include catheter-related infections, particularly in pediatric populations, and guidewire-mediated complications during placement. The risk of complications can be influenced by the surgical technique and the use of imaging guidance.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to standardize techniques and improve safety outcomes across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for central venous access catheter?
The device is indicated for patients requiring long-term intravenous therapy, such as chemotherapy, parenteral nutrition, and difficult venous access.
What outcomes have been reported in clinical studies?
Studies have reported that surgical experience and imaging guidance significantly impact the success and safety of catheter placement.
What complications have been reported?
Safety data indicate risks of catheter-related infections and guidewire-mediated complications, with imaging guidance helping to mitigate some risks.
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.