📊 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 ?
510(k)
Number ?
K881504 ↗
Decision Date ?
June 22, 1988
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous catheterization of a vein to establish venous access.
- Central venous catheterization using a percutaneous technique.
- Use in diagnostic or therapeutic procedures requiring venous access, as specified in the device labeling.
Clinical Applications
- Establishing central venous access for administration of medications or fluids.
- Providing venous access for parenteral nutrition when clinically indicated.
- Obtaining venous access for diagnostic procedures or hemodynamic monitoring.
- Supporting central venous access during critical care or surgical treatment.
Reported off-label uses
- Use as an access catheter during selected endovascular venous procedures, when the specific catheter configuration and labeling are appropriate.
- Use for venography or contrast injection when the catheter's pressure and flow specifications permit it.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The kit's catheter diameter, length, lumen configuration, and included components should be selected for the target vein, access route, patient size, and intended infusion or monitoring purpose.
- Placement should use sterile technique and appropriate imaging or physiologic confirmation, such as ultrasound for venous puncture and radiography or fluoroscopy for central catheter position when indicated.
- Compatibility with guidewires, introducers, connectors, contrast agents, infusion pumps, and other accessories must be confirmed before use.
- The record provided does not establish MRI safety. MRI conditions should be verified from the current device labeling or manufacturer before scanning.
- Potential contraindications and precautions include infection at the access site, thrombosed or unsuitable veins, coagulopathy, allergy to device materials or agents used during placement, and inability to safely maintain catheter sterility.
Procedures that use this 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.