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reinforced catheter introducer system rcis
Thomas Medical Products
Summary: The Reinforced Catheter Introducer System (RCIS) by Thomas Medical Products is a device used to facilitate the introduction of catheters into the vascular system. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K081341 ↗
Decision Date
May 14, 2008
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The RCIS was cleared through the FDA 510(k) pathway on May 14, 2008, by Thomas Medical Products. It is classified as a Class 2 device under product code DYB.
What It Is
The Reinforced Catheter Introducer System (RCIS) is a medical device designed to aid in the insertion of catheters into the vascular system. It features a reinforced sheath that provides stability and support during catheter placement. This system is essential in procedures requiring precise catheter positioning, reducing the risk of vessel trauma.
Clinical Applications
The RCIS is commonly used in interventional cardiology and radiology for procedures such as angiography, embolization, and other catheter-based interventions. It is particularly useful in settings where vascular access is challenging, such as in patients with tortuous or fragile vessels. The device is suitable for adult patients undergoing diagnostic or therapeutic vascular procedures.
Indications for Use
The FDA-cleared indications for the RCIS include facilitating the introduction of catheters into the vascular system. This is particularly relevant for patients requiring embolization procedures or other interventions involving vascular access.
Practical Considerations
The RCIS typically comes in various sizes to accommodate different patient anatomies and catheter sizes. It is compatible with standard catheter systems and requires careful technique to ensure proper placement and minimize complications. Clinicians should be familiar with the device's handling and insertion techniques.
Frequently Asked Questions
What is the Reinforced Catheter Introducer System RCIS used for?
The RCIS is used to facilitate the introduction of catheters into the vascular system, particularly in interventional cardiology and radiology procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use the RCIS in their procedures.
What are the FDA-cleared indications?
The RCIS is indicated for facilitating the introduction of catheters into the vascular system, especially for procedures like embolization.
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.