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Venous Catheter
Cardio Search
Summary: The venous catheter by Cardio Search is a Class 2 medical device used for central venous access. Key evidence highlights rare but serious complications such as cardiac tamponade.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K832064 ↗
Decision Date ?
August 8, 1983
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The venous catheter by Cardio Search was cleared through the FDA 510(k) pathway on August 8, 1983. It is classified as a Class 2 device under product code DQY.
What It Is
A venous catheter is a medical device designed for insertion into a central vein to provide prolonged access to the venous system. It is primarily used for administering medications, fluids, and nutritional supplements.
FDA-Cleared Indications
- Percutaneous catheterization of a vein to provide access to the venous system.
- Administration of medications, fluids, nutritional solutions, blood products, or other prescribed intravenous therapy when compatible with the catheter.
- Use in patients who require prolonged or repeated venous access, as specified by the individual device labeling.
Clinical Applications
- Central venous access for prolonged intravenous medication therapy.
- Administration of parenteral nutrition.
- Administration of blood products and intravenous fluids.
- Venous access during selected endovascular procedures, including venous thrombectomy or venous stenting, when the catheter is compatible with the procedure.
Reported off-label uses
- Use as venous access for administration of medications or infusions beyond the specific indications in the individual product labeling.
- Use as an access catheter during procedures not specifically listed in the product labeling, based on clinician judgment and device compatibility.
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 15 studies, comprising RCTs, prospective, retrospective, and case series, published between 2019 and 2024. These studies explore various aspects of venous catheter use, including complications and clinical outcomes.
Reported Outcomes
Published studies report that venous catheters are effective for central venous access, facilitating the administration of intravenous therapies. However, complications such as cardiac tamponade, extravasation, and hepatic complications in neonates have been documented.
Safety Profile
Reported complications include cardiac tamponade, which, although rare, has a high mortality rate. Other complications involve extravasation injuries and catheter-related infections, particularly in neonates.
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 better understand long-term outcomes and optimize safety protocols.
Practical Considerations
- Catheter diameter, length, lumen configuration, flow rate, and material must match the intended vessel, infusion, and procedure.
- Placement is typically performed using sterile technique and imaging guidance, such as ultrasound and fluoroscopy, depending on the access site and clinical situation.
- Compatibility with medications, contrast media, guidewires, introducers, and injection pressures should be confirmed before use.
- MRI safety is device-specific; verify the exact catheter model and labeling before an MRI examination. Do not assume that every venous catheter is MR Safe or MR Conditional.
- Potential complications include infection, bleeding, venous thrombosis, catheter malposition, vessel injury, air embolism, arrhythmia, and rare serious complications such as cardiac perforation or tamponade.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for venous catheter?
Venous catheters are indicated for central venous access to administer medications, fluids, and nutritional support.
What outcomes have been reported in clinical studies?
Studies report effective central venous access with rare but serious complications such as cardiac tamponade and hepatic complications in neonates.
What complications have been reported?
Safety data indicate complications such as cardiac tamponade, extravasation, and catheter-related infections.
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.