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olympus angioscopy irrigation sheath
Olympus
Summary: The Olympus Angioscopy Irrigation Sheath is a medical device used in angioscopy procedures to provide a clear view of blood vessels. It is primarily used by interventional cardiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K910933 ↗
Decision Date
June 3, 1991
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Olympus Angioscopy Irrigation Sheath was cleared through the FDA 510(k) pathway on June 3, 1991. Manufactured by Olympus, this device is classified as Class 2 under product code DYB.
What It Is
The Olympus Angioscopy Irrigation Sheath is a specialized sheath designed to facilitate angioscopy procedures by providing irrigation to clear blood and debris from the field of view. This device helps clinicians visualize the interior of blood vessels, aiding in the diagnosis and treatment of vascular conditions. It is typically used in conjunction with an angioscope, allowing for direct visualization of the vessel lumen.
Clinical Applications
This device is commonly used in interventional cardiology and vascular surgery settings. It is particularly useful in procedures requiring detailed visualization of blood vessels, such as evaluating the placement of embolization coils or assessing vascular lesions. The sheath is suitable for use in both hospital and outpatient settings, often involving patients with complex vascular conditions.
Indications for Use
The FDA-cleared indications suggest that this device is intended for use in procedures requiring direct visualization of blood vessels. It is particularly beneficial for patients undergoing interventions where precise placement and assessment of vascular devices are critical.
Practical Considerations
The Olympus Angioscopy Irrigation Sheath is available in various sizes to accommodate different vessel diameters. It is compatible with standard angioscopes and requires careful handling to ensure optimal irrigation and visualization. Clinicians should be familiar with the technique of angioscopy to maximize the device's effectiveness.
Frequently Asked Questions
What is the Olympus Angioscopy Irrigation Sheath used for?
It is used to provide irrigation during angioscopy procedures, allowing for clear visualization of blood vessels.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring direct visualization of blood vessels, such as during the placement of embolization coils.
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.