đź“‹ FDA Reference
modification to pinnacle roii hiflow introducer sheath
Terumo Medical
Summary: The Pinnacle ROII HiFlow Introducer Sheath is a medical device used to facilitate the introduction of catheters and other devices into the vascular system. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K062446 ↗
Decision Date
October 23, 2006
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Pinnacle ROII HiFlow Introducer Sheath was cleared through the FDA 510(k) pathway on October 23, 2006. It is manufactured by Terumo Medical and classified as a Class 2 device.
What It Is
The Pinnacle ROII HiFlow Introducer Sheath is a vascular access device designed to provide a conduit for the insertion of catheters and other interventional devices into the vascular system. It features a high-flow design that allows for efficient blood flow while maintaining access. The sheath is typically used in procedures requiring vascular access, such as angiography or the deployment of embolization coils.
Clinical Applications
This device is commonly used in interventional radiology and cardiology procedures. It is particularly useful in settings where rapid and reliable vascular access is needed, such as during embolization procedures or when deploying stents. The sheath is suitable for use in a variety of patient populations, including those undergoing treatment for vascular diseases or conditions requiring catheter-based interventions.
Indications for Use
The FDA indications for the Pinnacle ROII HiFlow Introducer Sheath include its use in facilitating the introduction of catheters and other devices into the vascular system. It is intended for patients requiring vascular access for diagnostic or therapeutic procedures.
Practical Considerations
The Pinnacle ROII HiFlow Introducer Sheath is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and interventional devices. Clinicians should be familiar with the insertion technique and ensure proper sizing to minimize complications.
Frequently Asked Questions
What is the Pinnacle ROII HiFlow Introducer Sheath used for?
It is used to facilitate the introduction of catheters and other devices into the vascular system, commonly in interventional radiology and cardiology procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in procedures requiring vascular access.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction of catheters and other devices into the vascular system for diagnostic or therapeutic 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.