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guider catheter introducer
Rhythm Xience, Inc. (Rxi)
Summary: The Guider Catheter Introducer by Rhythm Xience, Inc. is a medical device used primarily in interventional radiology and cardiology for the introduction of catheters into the vascular system. It is utilized by healthcare professionals during procedures requiring precise catheter placement.
FDA Clearance Information
Pathway
510K
Number
K171081 ↗
Decision Date
May 9, 2017
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Guider Catheter Introducer was cleared through the FDA 510(k) pathway on May 9, 2017. Manufactured by Rhythm Xience, Inc., it is classified as a Class 2 device under the product code DYB.
What It Is
The Guider Catheter Introducer is a specialized medical device designed to facilitate the insertion of catheters into the vascular system. It provides a stable pathway for catheters during diagnostic and therapeutic procedures. The device's design ensures minimal trauma to the vessel and allows for precise navigation to the target site.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings, particularly for procedures involving embolization or the placement of coils. It is suitable for use in both inpatient and outpatient settings, and is often employed in the treatment of vascular conditions in adult patients. Its use is critical in procedures that require high precision and control.
Indications for Use
The Guider Catheter Introducer is indicated for use in procedures requiring the introduction of catheters into the vascular system, such as embolization and coil placement. It is suitable for patients undergoing interventional procedures where vascular access is necessary.
Practical Considerations
The device is typically available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard catheter systems and requires careful handling to ensure proper placement and minimize vascular trauma.
Related Literature
The linked study explored the feasibility of using electromagnetic device tracking combined with CT/US/FDG PET fusion for real-time feedback during biopsies and hepatic RF ablation. It demonstrated that this multimodal approach could enhance the precision of percutaneous and intraoperative procedures. However, the study was limited by its focus on a specific patient population and the need for specialized equipment.
Frequently Asked Questions
What is the Guider Catheter Introducer used for?
It is used for the introduction of catheters into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring catheter introduction into the vascular system, such as embolization and coil placement.
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.