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central venous access catheter cvac-xx
Gish Biomedical
Summary: The central venous access catheter CVAC-XX by Gish Biomedical is used for venous access in critically ill patients. Key evidence highlights its role in preventing occlusions and infections.
FDA Clearance Information
Pathway
510K
Number
K841587 ↗
Decision Date
June 13, 1984
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The CVAC-XX was cleared by the FDA via the 510(k) pathway on June 13, 1984. It is manufactured by Gish Biomedical and classified as a Class 2 device.
What It Is
The central venous access catheter CVAC-XX is designed for insertion into a central vein to provide venous access for critically ill patients. It facilitates the administration of medications, fluids, and nutritional support.
Clinical Applications
Commonly used in intensive care settings, the CVAC-XX is indicated for patients requiring long-term venous access for treatments such as chemotherapy, parenteral nutrition, or hemodialysis.
Evidence Summary
The literature includes 10 studies, ranging from 2021 to 2025, encompassing RCTs, narrative reviews, and consensus documents. These studies explore catheter management, lock solutions, and infection prevention.
Reported Outcomes
Published studies report that the CVAC-XX is effective in maintaining venous access and reducing the incidence of occlusions when proper flushing protocols are followed. However, the efficacy of heparin versus saline for locking remains inconclusive.
Safety Profile
Reported complications include catheter-related infections and thrombosis. Studies emphasize the importance of proper insertion techniques and maintenance protocols to minimize these risks.
Evidence Limitations
The evidence is limited by the lack of consensus on optimal lock solutions and the need for more focused studies on critically ill populations. Further research is needed to establish standardized protocols for catheter management.
Frequently Asked Questions
What are the clinical indications for central venous access catheter CVAC-XX?
The CVAC-XX is indicated for patients requiring long-term central venous access for treatments such as chemotherapy, parenteral nutrition, or hemodialysis.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of venous access and reduced occlusions with proper flushing protocols, though the efficacy of heparin versus saline for locking is inconclusive.
What complications have been reported?
Reported complications include catheter-related infections and thrombosis, highlighting the need for proper insertion and maintenance protocols.
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.