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cordis catheter sheath introducers steri-sleeves
Cordis
Summary: Cordis Catheter Sheath Introducers Steri-Sleeves are used for vascular access in various procedures. Key evidence highlights their utility in central venous access and coronary angioplasty.
FDA Clearance Information
Pathway
510K
Number
K855126 ↗
Decision Date
February 26, 1986
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Cordis Catheter Sheath Introducers Steri-Sleeves were cleared by the FDA via the 510(k) pathway on February 26, 1986. Manufactured by Cordis, they are classified as Class 2 devices.
What It Is
The Cordis Catheter Sheath Introducers Steri-Sleeves are designed to facilitate vascular access by providing a stable conduit for catheters. They are primarily used in procedures requiring central venous access and coronary interventions.
Clinical Applications
These devices are commonly used in clinical scenarios such as central venous catheterization for hemodynamic monitoring and coronary angioplasty. They are particularly useful in settings requiring rapid and efficient vascular access.
Evidence Summary
The available literature includes four studies ranging from 1979 to 2022. These studies encompass various methodologies, including RCTs and case series, providing insights into the device's clinical applications.
Reported Outcomes
Published studies report successful use of the Cordis sheath introducers in central venous access and coronary angioplasty. One study demonstrated an 80% success rate in angioplasty using 4F catheters. Another study highlighted the device's role in improving hemostasis with microcrystalline chitosan.
Safety Profile
Reported complications include vascular spasm and pain when larger introducer sheaths are used, particularly in distal transradial artery access. No significant adverse events were noted in the studies reviewed.
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 safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Cordis Catheter Sheath Introducers Steri-Sleeves?
The clinical indications include central venous access and coronary angioplasty, as supported by the reviewed studies.
What outcomes have been reported in clinical studies?
Studies report successful central venous access and an 80% success rate in coronary angioplasty using 4F catheters.
What complications have been reported?
Safety data indicate potential for vascular spasm and pain with larger sheaths, especially in distal transradial artery access.
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.