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device modification to pinnacle destination peripheral guiding sheath
Terumo Medical
Summary: The Pinnacle Destination Peripheral Guiding Sheath is a device used in embolization procedures. It is primarily utilized to facilitate the delivery of embolization coils. Key evidence includes FDA clearance and linked studies, though specific outcomes and safety data are not detailed.
FDA Clearance Information
Pathway
510K
Number
K080415 ↗
Decision Date
March 7, 2008
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Pinnacle Destination Peripheral Guiding Sheath was cleared by the FDA via the 510(k) pathway on March 7, 2008. It is manufactured by Terumo Medical and classified as a Class 2 device under product code DYB.
What It Is
The Pinnacle Destination Peripheral Guiding Sheath is a medical device designed to assist in the delivery of embolization coils during interventional procedures. It provides a stable platform for catheter-based interventions in peripheral vasculature.
Clinical Applications
This device is commonly used in procedures requiring embolization, particularly in cases involving peripheral vascular access. It is instrumental in providing support and stability for the delivery of therapeutic agents or devices.
Evidence Summary
The available literature includes five linked studies, though specific details on study types, total sample sizes, and date ranges are not provided. The studies are registered on ClinicalTrials.gov but lack detailed outcomes and safety data.
Reported Outcomes
Published studies report limited specific efficacy findings for the Pinnacle Destination Peripheral Guiding Sheath. The linked studies do not provide detailed outcomes related to the device's performance or clinical efficacy.
Safety Profile
Reported complications include limited safety data from the linked studies. Specific adverse events or complications related to the use of the Pinnacle Destination Peripheral Guiding Sheath are not detailed in the provided evidence.
Evidence Limitations
The evidence base for the Pinnacle Destination Peripheral Guiding Sheath is limited by the lack of detailed outcomes and safety data in the linked studies. Further research is needed to better understand the device's clinical efficacy and safety profile.
Frequently Asked Questions
What are the clinical indications for Pinnacle Destination Peripheral Guiding Sheath?
The device is indicated for use in embolization procedures, particularly for facilitating the delivery of embolization coils in peripheral vasculature.
What outcomes have been reported in clinical studies?
Specific findings from the linked studies are not detailed, limiting the available information on clinical outcomes.
What complications have been reported?
Safety data from the linked studies is limited, with no specific complications detailed in the provided evidence.
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.