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datascope s 10 fr flexisheath percutaneous introducer
Datascope
Summary: The Datascope S 10 Fr Flexisheath Percutaneous Introducer is a medical device used for vascular access during procedures such as embolization. It is typically used by interventional radiologists or cardiologists.
FDA Clearance Information
Pathway
510K
Number
K973007 ↗
Decision Date
November 6, 1997
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Datascope S 10 Fr Flexisheath was cleared via the FDA 510(k) pathway on November 6, 1997. It is manufactured by Datascope and is classified as a Class 2 device under product code DYB.
What It Is
The Datascope S 10 Fr Flexisheath Percutaneous Introducer is a sheath used to facilitate the insertion of catheters or other devices into the vascular system. It is designed to provide a stable and flexible conduit for accessing blood vessels, minimizing trauma to the vessel wall during insertion and manipulation. Its flexibility allows it to navigate tortuous vascular anatomy effectively.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures requiring vascular access, such as embolization, angiography, or the placement of stents. It is suitable for use in both adult and pediatric populations, depending on the size of the vasculature. The introducer is typically used in hospital settings, particularly in catheterization labs or interventional suites.
Indications for Use
The FDA indications suggest that this device is used for gaining percutaneous access to the vascular system. It is applicable in patients requiring interventions like embolization, where precise and stable access to blood vessels is crucial.
Practical Considerations
The Datascope S 10 Fr Flexisheath is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and guidewires. Clinicians should be familiar with the technique of sheath insertion to minimize complications such as vessel trauma or bleeding.
Related Literature
The linked study investigated oscillometric blood pressure norms in non-overweight children and adolescents in Lubumbashi, DRC. It aimed to establish local BP thresholds and compare them with international references. The study highlighted the variability in BP norms across different populations, emphasizing the need for region-specific data. However, it did not directly relate to the use of the Datascope S 10 Fr Flexisheath.
Frequently Asked Questions
What is the Datascope S 10 Fr Flexisheath Percutaneous Introducer used for?
It is used for gaining vascular access during procedures like embolization or angiography.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for percutaneous access to the vascular system for procedures requiring stable and flexible access.
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.