đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Facilitation of the introduction of catheters into the vascular system.
Clinical Applications
- Providing vascular access for catheter-based diagnostic procedures such as angiography.
- Supporting catheter introduction during embolization procedures.
- Facilitating access for other vascular interventions that require introduction of a catheter through an introducer sheath.
Practical Considerations
- Available sizes and configurations should be matched to the planned catheter, guidewire, access vessel and patient anatomy.
- The reinforced sheath is intended to provide support and resistance to kinking, but careful advancement is required to reduce the risk of vessel injury.
- Use requires sterile technique, appropriate vascular-access imaging and familiarity with introducer-sheath handling.
- MRI safety depends on the specific device materials and labeling; confirm the current manufacturer’s MRI conditions before scanning a patient with the device in place.
- Contraindications, warnings and compatibility information should be reviewed in the current instructions for use. The system is generally intended for temporary procedural access rather than long-term implantation.
Procedures that use this device
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.