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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
510K
Number
K832064 ↗
Decision Date
August 8, 1983
Product Code
DQY
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.
Clinical Applications
Venous catheters are commonly used in hospital settings for patients requiring long-term intravenous therapy, including chemotherapy, parenteral nutrition, and administration of blood products.
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.
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.