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cordis catheter sheath introducer
Cordis
Summary: The Cordis Catheter Sheath Introducer is a device used for vascular access, primarily in central venous catheterization. Key evidence highlights its utility in complex vascular procedures with a focus on minimizing complications.
FDA Clearance Information
Pathway
510K
Number
K932733 ↗
Decision Date
August 26, 1993
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Cordis Catheter Sheath Introducer was cleared via the FDA 510(k) pathway on August 26, 1993. It is manufactured by Cordis and classified as a Class 2 device.
What It Is
The Cordis Catheter Sheath Introducer is a medical device designed to facilitate the insertion of catheters into the vascular system. It is equipped with a hemostatic valve to prevent blood loss and is commonly used in central venous catheterization.
Clinical Applications
This device is frequently used in procedures requiring central venous access, such as hemodynamic monitoring and infusion of multiple solutions. It is particularly useful in critically ill patients where rapid and efficient catheterization is necessary.
Evidence Summary
The available literature includes a mix of study types, such as RCTs and case series, with a total of 5 studies spanning from 1979 to 2022. These studies explore various applications and outcomes of the device.
Reported Outcomes
Published studies report successful use of the Cordis Catheter Sheath Introducer in complex vascular procedures, including coronary angioplasty and central venous access. The device has been shown to improve hemostasis and facilitate efficient catheterization in critically ill patients.
Safety Profile
Reported complications include vascular spasm and pain when larger introducer sheaths are used, particularly in distal transradial artery procedures. However, the use of slender techniques may mitigate these issues.
Evidence Limitations
The evidence is limited by the small number of studies and the variability in study design. Further research is needed to explore long-term outcomes and to validate findings across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Cordis Catheter Sheath Introducer?
The device is indicated for use in central venous catheterization and other procedures requiring vascular access.
What outcomes have been reported in clinical studies?
Studies have reported successful catheterization and improved hemostasis, particularly in complex vascular procedures.
What complications have been reported?
Safety data indicate potential complications such as vascular spasm and pain, especially with larger sheath sizes.
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.