đź“‹ FDA Reference
pinnacle r o or redifocus introducer r o comprised of a sheath dilator
Terumo Medical
Summary: The Pinnacle R/O or Redifocus Introducer R/O is a medical device used for vascular access during procedures such as embolization. It is typically used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K984260 ↗
Decision Date
January 26, 1999
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Pinnacle R/O or Redifocus Introducer R/O was cleared through the FDA 510(k) pathway on January 26, 1999. Manufactured by Terumo Medical, it is classified as a Class 2 device.
What It Is
The Pinnacle R/O or Redifocus Introducer R/O is a sheath and dilator system designed to facilitate the introduction of catheters and other devices into the vascular system. It provides a stable and secure access point, minimizing trauma to the vessel wall. The device is particularly useful in procedures requiring precision and stability, such as the placement of embolization coils.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures requiring vascular access, such as embolization, angiography, and catheter-based interventions. It is suitable for use in both hospital and outpatient settings, catering to a wide range of patient populations, including those undergoing treatment for vascular anomalies or blockages.
Indications for Use
The device is indicated for use in patients requiring vascular access for the delivery of therapeutic agents or devices, such as embolization coils. It is particularly beneficial for patients with conditions that necessitate precise and stable catheter placement.
Practical Considerations
The Pinnacle R/O or Redifocus Introducer R/O is available in various sizes to accommodate different vessel diameters. It is compatible with a range of catheters and guidewires, making it versatile for multiple procedures. Clinicians should ensure proper sizing and technique to minimize complications.
Frequently Asked Questions
What is Pinnacle R/O or Redifocus Introducer R/O used for?
It is used for vascular access during procedures like embolization, allowing for the introduction of catheters and other devices.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for vascular access to facilitate the delivery of therapeutic agents or devices, such as embolization coils.
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.