đź“Š Evidence-Based Reference
ez-intro percutaneous catheter sheath ez-intro vessel dilator
Adam Spence
Summary: The ez-intro percutaneous catheter sheath by Adam Spence is primarily used for vascular access in procedures requiring catheter insertion. Key evidence highlights its role in facilitating hemostasis and reducing complications in venous access.
FDA Clearance Information
Pathway 510K
Number K983940 ↗
Decision Date July 15, 1999
Product Code DYB
Device Class Class 2
Evidence 0 studies
The ez-intro percutaneous catheter sheath was cleared by the FDA via the 510(k) pathway on July 15, 1999. It is manufactured by Adam Spence and classified as a Class 2 device.
What It Is
The ez-intro percutaneous catheter sheath is a medical device designed to facilitate the insertion of catheters into blood vessels. It is used in various clinical settings to ensure safe and efficient vascular access, particularly in procedures requiring embolization coils.
Clinical Applications
This device is commonly used in procedures that require reliable vascular access, such as hemodialysis and percutaneous coronary interventions. It is particularly useful in scenarios where immediate access is necessary, despite potential complications.
Evidence Summary
The available literature includes 10 studies, comprising RCTs, prospective, retrospective, and case series, published between 2016 and 2023. These studies explore various aspects of vascular access and device efficacy.
Reported Outcomes
Published studies report that the ez-intro percutaneous catheter sheath effectively facilitates vascular access with a focus on reducing intrarenal pressure during procedures and achieving hemostasis. It is associated with improved procedural safety and efficiency.
Safety Profile
Reported complications include potential infectious and thrombotic events, as well as technical issues that may limit the device's lifespan. These are consistent with known risks associated with central venous catheters.
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 explore long-term outcomes and compare efficacy with alternative devices.
Frequently Asked Questions
What are the clinical indications for ez-intro percutaneous catheter sheath?
The device is indicated for use in procedures requiring reliable vascular access, such as hemodialysis and percutaneous coronary interventions.
What outcomes have been reported in clinical studies?
Studies report effective facilitation of vascular access, improved procedural safety, and reduced intrarenal pressure during procedures.
What complications have been reported?
Safety data indicate potential infectious and thrombotic complications, as well as technical issues that may limit device lifespan.
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.