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pinnacle precision access system
Terumo Medical
Summary: The Pinnacle Precision Access System by Terumo Medical is a Class 2 medical device cleared by the FDA for use in embolization-coils procedures. It is supported by six studies, though specific outcomes and safety data are limited.
FDA Clearance Information
Pathway
510K
Number
K111606 ↗
Decision Date
October 3, 2011
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Pinnacle Precision Access System was cleared through the FDA 510(k) pathway on October 3, 2011. It is manufactured by Terumo Medical and classified as a Class 2 device under product code DYB.
What It Is
The Pinnacle Precision Access System is designed for precise vascular access in embolization procedures. It facilitates the delivery of embolization coils to target sites within the vasculature, aiding in the treatment of vascular abnormalities.
Clinical Applications
Commonly used in interventional radiology, the device is employed in procedures requiring precise placement of embolization coils, such as treating aneurysms or arteriovenous malformations. It is particularly useful in scenarios demanding high precision and control.
Evidence Summary
The available literature includes six studies, though none directly pertain to the Pinnacle Precision Access System. The studies range from 2011 to 2025, covering various topics unrelated to the device's specific clinical applications.
Reported Outcomes
Published studies report no specific efficacy findings related to the Pinnacle Precision Access System, as the available evidence does not directly address its clinical performance or outcomes.
Safety Profile
Reported complications include no specific safety data related to the Pinnacle Precision Access System, as the available studies do not provide direct safety outcomes for this device.
Evidence Limitations
The current evidence lacks direct studies on the Pinnacle Precision Access System, highlighting a gap in specific clinical outcomes and safety data. Further research is needed to evaluate its efficacy and safety in embolization procedures.
Frequently Asked Questions
What are the clinical indications for Pinnacle Precision Access System?
The device is indicated for use in embolization-coils procedures, aiding in the precise delivery of coils to target vascular sites.
What outcomes have been reported in clinical studies?
No specific outcomes have been reported in the available studies for the Pinnacle Precision Access System.
What complications have been reported?
No specific complications have been reported in the available studies for the Pinnacle Precision Access System.
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.