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q-tips faichney private label
Faichney Medical
Summary: The Q-Tips Faichney Private Label is a Class 2 medical device used in portal vein procedures. It is typically utilized by specialists in vascular and interventional radiology.
FDA Clearance Information
Pathway
510K
Number
K962497 ↗
Decision Date
October 8, 1996
Product Code
FLL
Device Class
Class 2
Evidence
0 studies
The Q-Tips Faichney Private Label was cleared through the FDA 510(k) pathway on October 8, 1996. It is manufactured by Faichney Medical and classified as a Class 2 device under product code FLL.
What It Is
The Q-Tips Faichney Private Label is a specialized medical device designed for use in procedures involving the portal vein. It likely serves as an accessory or tool to facilitate access or intervention in the portal venous system. This device is part of a category of tools used to ensure precision and safety during vascular procedures.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings, particularly in procedures involving the portal vein. It may be used in diagnostic or therapeutic interventions such as portal vein catheterization or embolization. The device is suitable for use in adult patients undergoing evaluation or treatment of portal hypertension or other portal vein-related conditions.
Indications for Use
The FDA-cleared indications suggest this device is intended for use in procedures involving the portal vein. It is likely used in patients with conditions affecting the portal venous system, such as portal hypertension or thrombosis.
Practical Considerations
Clinicians should consider the typical sizing and compatibility of the Q-Tips Faichney Private Label with other vascular access tools. Proper technique is essential to ensure safety and efficacy, and familiarity with portal vein anatomy is recommended for optimal use.
Frequently Asked Questions
What is Q-Tips Faichney Private Label used for?
It is used in procedures involving the portal vein, such as catheterization or embolization.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in procedures involving the portal vein, such as those addressing portal hypertension or thrombosis.
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.