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model sp5800 8 french intro kit
Gould
Summary: The Model SP5800 8 French Intro Kit by Gould is a medical device used primarily for vascular access in embolization procedures. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K823262 ↗
Decision Date
January 18, 1983
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Model SP5800 8 French Intro Kit was cleared through the FDA 510(k) pathway on January 18, 1983. Manufactured by Gould, it is classified as a Class 2 device under product code DYB.
What It Is
The Model SP5800 8 French Intro Kit is a vascular access device designed to facilitate the introduction of embolization coils into the vascular system. It consists of an introducer sheath and related components that allow for the safe and efficient delivery of therapeutic agents into blood vessels. This device is crucial in procedures where precise vascular access is required.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings for procedures involving the embolization of blood vessels, such as in the treatment of aneurysms or arteriovenous malformations. It is suitable for use in both hospital and outpatient settings, primarily involving adult patients who require vascular interventions.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures requiring vascular access for the delivery of embolization coils. It is suitable for patients requiring interventions to block blood flow to specific areas, such as in the treatment of vascular abnormalities.
Practical Considerations
The 8 French size of this intro kit indicates its compatibility with a wide range of embolization coils and catheters. Clinicians should ensure compatibility with other devices used in the procedure and be familiar with the technique for introducing the sheath to minimize complications.
Frequently Asked Questions
What is Model SP5800 8 French Intro Kit used for?
It is used for vascular access in embolization procedures to introduce embolization coils into the vascular system.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access for the delivery of embolization coils, such as treating vascular abnormalities.
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.