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percutaneous venous introducer 10264
Medamicus
Summary: The Percutaneous Venous Introducer 10264 by Medamicus is a medical device used to facilitate the insertion of catheters into veins. It is commonly used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K965167 ↗
Decision Date
July 25, 1997
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Percutaneous Venous Introducer 10264 was cleared through the FDA 510k pathway on July 25, 1997. Manufactured by Medamicus, it is classified as a Class 2 device under product code DYB.
What It Is
The Percutaneous Venous Introducer 10264 is a medical device designed to provide access to the venous system for the insertion of catheters. It typically consists of a sheath and dilator, allowing for smooth entry into the vein while minimizing trauma. This device is essential in procedures requiring venous access, such as the placement of central venous catheters or other vascular devices.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in procedures that require the introduction of embolization coils or other therapeutic devices into the venous system. Patients who may benefit from this device include those needing long-term intravenous therapy, hemodialysis, or those undergoing complex vascular interventions.
Indications for Use
The FDA indications for this device include facilitating the insertion of catheters into the venous system. It is suitable for patients requiring venous access for various medical procedures, including embolization and other interventional techniques.
Practical Considerations
When using the Percutaneous Venous Introducer 10264, clinicians should be aware of the typical sizes available and ensure compatibility with the catheters being used. Proper technique is crucial to avoid complications such as vessel trauma or infection.
Frequently Asked Questions
What is the Percutaneous Venous Introducer 10264 used for?
It is used to facilitate the insertion of catheters into the venous system, often in interventional radiology or vascular surgery.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for facilitating the insertion of catheters into the venous system for various medical 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.