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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 ?
510(k)
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.
FDA-Cleared Indications
- Use in procedures involving access to the portal vein.
- Use with compatible catheter systems for portal venous diagnostic or therapeutic procedures.
Clinical Applications
- Portal vein catheterization.
- Portal venography and other diagnostic portal venous procedures.
- Portal venous access during liver-related surgery or intervention when specified by the applicable labeling.
- Access for treatment of portal venous conditions when used according to the device labeling and compatible system instructions.
Practical Considerations
- The available vessel tip sizes are 13 through 18; selection should match the patient's vascular anatomy and the planned catheter system.
- Confirm compatibility with the catheter, introducer, guidewire, and other equipment before use.
- Use requires training in portal venous access and image-guided vascular procedures.
- The supplied FDA record does not establish MRI safety; review the current labeling and device materials before MRI exposure.
- Do not use when the device, packaging, or compatible system is damaged, incompatible, or contraindicated by the manufacturer's instructions.
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.