đź“Š Evidence-Based Reference
ven-a-cath percutaneous venous catheter kit
Hdc
Summary: The ven-a-cath percutaneous venous catheter kit by Hdc is a Class 2 medical device cleared by the FDA for venous access. It is primarily used for central venous catheterization. Key evidence includes studies on guidewire length and vascular access techniques.
FDA Clearance Information
Pathway
510K
Number
K881504 ↗
Decision Date
June 22, 1988
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The ven-a-cath percutaneous venous catheter kit was cleared through the FDA 510(k) pathway on June 22, 1988. It is manufactured by Hdc and classified as a Class 2 device.
What It Is
The ven-a-cath percutaneous venous catheter kit is designed for percutaneous venous access, facilitating central venous catheterization. It is used in various clinical settings to provide reliable venous access for therapeutic and diagnostic purposes.
Clinical Applications
Commonly used in scenarios requiring central venous access, such as administration of medications, fluids, or parenteral nutrition, and for hemodynamic monitoring. It is particularly useful in critical care and surgical settings.
Evidence Summary
The literature includes 10 studies, with a mix of RCTs, case series, and retrospective analyses, spanning from 2012 to 2023. These studies explore various aspects of venous catheterization, including technique optimization and safety.
Reported Outcomes
Published studies report that the ven-a-cath kit is effective in achieving central venous access with minimal complications. Techniques such as ultrasound guidance have been shown to reduce misplacement rates and improve procedural success.
Safety Profile
Reported complications include potential misplacement of the catheter, which can be mitigated by using ultrasound guidance. Other studies highlight the risk of vascular injury and bleeding, emphasizing the need for careful technique.
Evidence Limitations
The evidence is limited by the variability in study designs and small sample sizes in some cases. Further research is needed to establish standardized protocols and long-term outcomes associated with the device.
Frequently Asked Questions
What are the clinical indications for ven-a-cath percutaneous venous catheter kit?
The device is indicated for central venous access in patients requiring medication administration, fluid therapy, or hemodynamic monitoring.
What outcomes have been reported in clinical studies?
Studies report effective central venous access with reduced misplacement rates when using ultrasound guidance.
What complications have been reported?
Safety data indicate risks of catheter misplacement and vascular injury, which can be minimized with proper technique and guidance.
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.