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destination renal guiding sheath
Terumo Medical
Summary: The destination renal guiding sheath by Terumo Medical is a device used primarily in embolization procedures. It is FDA 510k cleared and linked to five studies, though specific outcomes and safety data are not detailed.
FDA Clearance Information
Pathway
510K
Number
K081045 ↗
Decision Date
May 28, 2008
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The destination renal guiding sheath was cleared by the FDA via the 510k pathway on May 28, 2008. It is manufactured by Terumo Medical and classified as a Class 2 device under product code DYB.
What It Is
The destination renal guiding sheath is a medical device designed to facilitate the delivery of embolization coils during interventional procedures. It is intended for use in renal interventions, providing support and guidance for other instruments.
Clinical Applications
This device is commonly used in procedures requiring embolization, particularly in renal interventions. It aids in the precise placement of embolization coils, which are used to block blood flow to specific areas.
Evidence Summary
The available literature includes five studies linked to the device, 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 specific outcomes related to the destination renal guiding sheath. The studies are primarily focused on procedural interventions, but detailed efficacy findings are not available from the provided evidence.
Safety Profile
Reported complications include general procedural risks associated with embolization and renal interventions. However, specific adverse events related to the device are not detailed in the provided evidence.
Evidence Limitations
The evidence base for the destination renal guiding sheath is limited, with a lack of detailed study outcomes and safety data. Further research is needed to establish comprehensive efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for destination renal guiding sheath?
The device is indicated for use in embolization procedures, particularly in renal interventions, to facilitate the delivery of embolization coils.
What outcomes have been reported in clinical studies?
Specific outcomes from clinical studies are not detailed in the provided evidence, highlighting a gap in available data.
What complications have been reported?
Safety data from the evidence is limited, with general procedural risks noted but no specific complications detailed for the device.
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.