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vessel tips sizes 13-18
Quinton
Summary: Vessel tips sizes 13-18 by Quinton are used in portal vein procedures. They are typically utilized by vascular surgeons and interventional radiologists for precise vascular access.
FDA Clearance Information
Pathway 510K
Number K810257 ↗
Decision Date March 13, 1981
Product Code FKW
Device Class Class 2
Evidence 0 studies
This device was cleared through the FDA 510(k) pathway on March 13, 1981. Manufactured by Quinton, it is classified as a Class 2 device under product code FKW.
What It Is
The vessel tips sizes 13-18 are specialized medical devices designed for use in portal vein procedures. These tips facilitate the insertion and navigation of catheters within the vascular system, particularly in the portal vein. Their design allows for precise control and minimal trauma to the vessel walls, which is crucial in sensitive vascular procedures.
Clinical Applications
Commonly used in procedures involving the portal vein, these vessel tips are essential in settings like liver transplantation or treatment of portal hypertension. They are primarily used by vascular surgeons and interventional radiologists in hospital settings. The device is suitable for adult patients requiring portal vein access for diagnostic or therapeutic interventions.
Indications for Use
The FDA-cleared indications suggest these vessel tips are intended for use in procedures involving the portal vein. This includes patients with conditions like portal hypertension or those undergoing liver-related surgeries.
Practical Considerations
When selecting vessel tip sizes, consider the specific vascular anatomy and the procedure's requirements. Compatibility with existing catheter systems is essential, and practitioners should be trained in the technique to ensure optimal outcomes.
Frequently Asked Questions
What is vessel tips sizes 13-18 used for?
They are used for accessing and navigating the portal vein during vascular procedures.
What specialties typically use this device?
Vascular surgeons and interventional radiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the portal vein, such as those for portal hypertension or liver surgery.
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.