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pinnacle roii introducer sheath
Terumo Medical
Summary: The Pinnacle ROII Introducer Sheath is a medical device used to facilitate the introduction of catheters and other devices into the vascular system. It is commonly used by interventional radiologists and cardiologists during procedures such as embolization.
FDA Clearance Information
Pathway
510K
Number
K082847 ↗
Decision Date
October 29, 2008
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Pinnacle ROII Introducer Sheath was cleared through the FDA 510(k) pathway on October 29, 2008. Manufactured by Terumo Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The Pinnacle ROII Introducer Sheath is designed to provide a conduit for the introduction of catheters and other medical devices into the vascular system. It consists of a flexible tube that is inserted into a blood vessel, allowing for the smooth passage of instruments. This device is essential for procedures requiring vascular access, ensuring minimal trauma and improved procedural efficiency.
Clinical Applications
This introducer sheath is commonly used in interventional radiology and cardiology for procedures such as embolization, where precise catheter placement is crucial. It is used in both hospital and outpatient settings, catering to a wide range of patient populations requiring vascular interventions. The sheath's design facilitates easy access to the vascular system, making it a staple in procedures involving embolization coils.
Indications for Use
The Pinnacle ROII Introducer Sheath is indicated for use in patients requiring vascular access for the introduction of catheters and other devices. It is particularly useful in procedures involving embolization, where precise and stable device placement is necessary.
Practical Considerations
The Pinnacle ROII Introducer Sheath comes in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and embolization coils, and clinicians should be familiar with the insertion technique to ensure optimal outcomes and minimize complications.
Frequently Asked Questions
What is the Pinnacle ROII Introducer Sheath used for?
It is used to facilitate the introduction of catheters and other medical devices into the vascular system, particularly during embolization procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device during vascular access procedures.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring vascular access for the introduction of catheters and other devices, especially in embolization procedures.
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.