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transvenous balloon cath intro kit
Stanco Medical
Summary: The transvenous balloon catheter introduction kit by Stanco Medical is used for vascular access and catheter placement, primarily in interventional radiology and cardiology. It is typically utilized by clinicians in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K792130 ↗
Decision Date
November 13, 1979
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on November 13, 1979, and is manufactured by Stanco Medical. It is classified as a Class 2 medical device under product code DYB.
What It Is
The transvenous balloon catheter introduction kit is a medical device used to facilitate the insertion of balloon catheters into the venous system. It typically includes components such as a guidewire, introducer sheath, and dilator. The device is designed to provide safe and efficient vascular access, allowing for the placement of catheters used in various diagnostic and therapeutic procedures.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as angioplasty, embolization, and other vascular interventions. It is particularly useful in settings where precise catheter placement is crucial, such as in the treatment of vascular occlusions or aneurysms. The device is used in adult and pediatric populations, depending on the specific clinical scenario.
Indications for Use
The FDA indications for this device involve its use in facilitating the introduction of balloon catheters into the venous system. It is indicated for patients requiring vascular access for diagnostic or therapeutic interventions, such as those with vascular diseases or requiring embolization procedures.
Practical Considerations
Clinicians should consider the appropriate sizing of the introducer sheath and guidewire to match the specific balloon catheter being used. Compatibility with other vascular access devices should be verified. Proper technique in insertion and handling is essential to minimize complications such as vascular injury or infection.
Frequently Asked Questions
What is the transvenous balloon cath intro kit used for?
It is used for facilitating the insertion of balloon catheters into the venous system for various vascular interventions.
What specialties typically use this device?
Interventional radiology and cardiology are the primary specialties that use this device.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction of balloon catheters into the venous system for diagnostic and therapeutic vascular procedures.
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.