📋 FDA Reference
Modification to Pinnacle Roii Hiflow Introducer Sheath
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 ?
510(k)
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.
FDA-Cleared Indications
- Facilitation of catheter and other device introduction into the vascular system.
- Use as vascular access for diagnostic procedures.
- Use as vascular access for therapeutic procedures.
Clinical Applications
- Providing vascular access for angiography and other catheter-based diagnostic procedures.
- Providing a conduit for embolization procedures.
- Facilitating introduction of catheters and interventional devices during endovascular treatment.
- Maintaining access while compatible devices are exchanged or advanced through the vascular system.
Practical Considerations
- Available sizes and configurations should be matched to the access vessel, patient anatomy and intended catheter or device.
- The sheath must be compatible with the guidewire, catheter or interventional device being used.
- Insertion is performed using standard sterile vascular-access technique, commonly with fluoroscopic or other imaging guidance.
- Potential access-site complications include bleeding, hematoma, infection, arterial injury, thrombosis and distal ischemia.
- MRI safety depends on the specific sheath configuration and labeling; users should verify the current manufacturer instructions before MRI exposure.
Procedures that use this device
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.