đź“Š Evidence-Based Reference
models sp5825 sp5835 sp5845 sp5855 percu sheath
Spectramed
Summary: The Spectramed percu sheath models SP5825-SP5855 are used in embolization procedures. They are FDA 510k cleared and linked to 10 studies, though specific outcomes and safety data are not detailed in the provided evidence.
FDA Clearance Information
Pathway 510K
Number K881825 ↗
Decision Date September 28, 1988
Product Code DYB
Device Class Class 2
Evidence 0 studies
The Spectramed percu sheath models SP5825-SP5855 were cleared via the FDA 510k pathway on September 28, 1988. They are classified as Class 2 devices under product code DYB.
What It Is
The percu sheath models SP5825-SP5855 are medical devices designed for use in embolization procedures. They facilitate the introduction of embolization coils into the vasculature, aiding in the occlusion of blood vessels.
Clinical Applications
These devices are commonly used in interventional radiology for procedures requiring vascular access and embolization, such as treating aneurysms or arteriovenous malformations.
Evidence Summary
The available literature includes 10 studies, though the specific types and outcomes are not detailed in the provided evidence. The studies span various years, with some as recent as 2024.
Reported Outcomes
Published studies report limited specific outcomes related to the efficacy of the percu sheath models. The provided evidence does not detail specific clinical results or efficacy metrics.
Safety Profile
Reported complications include limited safety data, as the provided evidence does not specify adverse events or complications associated with the use of these devices.
Evidence Limitations
The evidence provided lacks detailed outcomes and safety data, highlighting a gap in comprehensive clinical findings. Further research is needed to establish specific efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for percu sheath models SP5825-SP5855?
The clinical indications are primarily for use in embolization procedures, as referenced in FDA documentation.
What outcomes have been reported in clinical studies?
The provided evidence does not specify detailed outcomes from clinical studies.
What complications have been reported?
Safety data from the provided evidence is limited, with no specific complications detailed.
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.