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rain sheath transradial
Cordis
Summary: The Rain Sheath Transradial is a medical device used in cardiology for vascular access during procedures. It is primarily used by interventional cardiologists.
FDA Clearance Information
Pathway
510K
Number
K181592 ↗
Decision Date
August 15, 2018
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Rain Sheath Transradial by Cordis was cleared through the FDA 510(k) pathway on August 15, 2018. It is a Class 2 device under product code DYB.
What It Is
The Rain Sheath Transradial is a vascular access sheath designed for transradial procedures, which involve accessing the arterial system via the radial artery in the wrist. This approach is often preferred for its reduced complication rates and quicker patient recovery compared to femoral access. The sheath facilitates the insertion of catheters and other instruments necessary for diagnostic and interventional cardiology procedures.
Clinical Applications
This device is commonly used in interventional cardiology settings, particularly for procedures such as coronary angiography and percutaneous coronary interventions (PCI). It is suitable for use in hospitals and specialized cardiac care centers, and is typically used in adult patients who require vascular access for cardiac procedures. The transradial approach is favored for its patient comfort and lower risk of bleeding complications.
Indications for Use
The Rain Sheath Transradial is indicated for use in patients requiring vascular access for cardiac procedures. It is specifically designed for accessing the radial artery, making it suitable for patients undergoing diagnostic or interventional cardiology procedures.
Practical Considerations
The Rain Sheath Transradial is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard interventional cardiology equipment. Clinicians should be trained in the transradial technique to optimize outcomes and minimize complications.
Related Literature
The linked PMCF study for cardiology access procedures investigated the use of the Rain Sheath Transradial in clinical settings. While specific findings and limitations are not detailed, such studies typically assess device performance, safety, and user satisfaction. These studies help validate the device's real-world efficacy and inform best practices.
Frequently Asked Questions
What is the Rain Sheath Transradial used for?
It is used for vascular access in cardiology procedures, particularly via the radial artery.
What specialties typically use this device?
Interventional cardiologists primarily use this device in cardiac procedures.
What are the FDA-cleared indications?
It is indicated for vascular access in patients undergoing cardiac procedures, specifically via the radial artery.
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.