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pinnacle r o ii or radifocus introducer ii
Terumo Medical
Summary: The Pinnacle R O II or Radifocus Introducer II is a medical device used primarily for embolization procedures. It is FDA-cleared and falls under Class 2 devices. Current evidence includes five studies, though specific outcomes and safety data are not detailed.
FDA Clearance Information
Pathway
510K
Number
K003424 ↗
Decision Date
November 21, 2000
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Pinnacle R O II or Radifocus Introducer II was cleared by the FDA via the 510(k) pathway on November 21, 2000. It is manufactured by Terumo Medical and classified as a Class 2 device under product code DYB.
What It Is
The Pinnacle R O II or Radifocus Introducer II is a device designed for use in embolization procedures. It facilitates the introduction of embolization coils into the vascular system, aiding in the treatment of various vascular conditions.
Clinical Applications
This device is commonly used in interventional radiology for procedures requiring the precise placement of embolization coils. It is particularly useful in managing conditions such as aneurysms or arteriovenous malformations.
Evidence Summary
The available literature includes five studies, though specific details on study types, sample sizes, and date ranges are not provided. The studies are registered on clinical trial databases but lack detailed outcomes and safety data.
Reported Outcomes
Published studies report limited information on the efficacy of the Pinnacle R O II or Radifocus Introducer II. Specific outcomes related to its use in embolization procedures are not detailed in the provided evidence.
Safety Profile
Reported complications include limited data on adverse events associated with the use of this device. The evidence provided does not specify particular safety concerns or complications.
Evidence Limitations
The evidence base for the Pinnacle R O II or Radifocus Introducer II is limited, with a lack of detailed study outcomes and safety data. Further research is needed to better understand its efficacy and safety profile in clinical practice.
Frequently Asked Questions
What are the clinical indications for Pinnacle R O II or Radifocus Introducer II?
The device is indicated for use in embolization procedures, particularly for the introduction of embolization coils in vascular interventions.
What outcomes have been reported in clinical studies?
Specific findings from the evidence are not detailed, with limited information on the efficacy of the device in the provided studies.
What complications have been reported?
Safety data from the evidence is limited, with no specific complications detailed in the provided studies.
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.