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creganna tactx lotus introducer set small creganna tactx lotus introducer set large
Creganna-Tactx Medical
Summary: The Creganna Tactx Lotus Introducer Set is a medical device used for vascular access during interventional procedures. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway 510K
Number K140338 ↗
Decision Date August 27, 2014
Product Code DYB
Device Class Class 2
Evidence 0 studies
The Creganna Tactx Lotus Introducer Set was cleared through the FDA 510(k) pathway on August 27, 2014. It is manufactured by Creganna-Tactx Medical and classified as a Class 2 device under product code DYB.
What It Is
The Creganna Tactx Lotus Introducer Set is designed to facilitate the introduction of catheters and other medical devices into the vascular system. It consists of a sheath and dilator, which help in minimizing trauma to the vessel during insertion. The device is available in different sizes to accommodate various procedural needs.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as embolization, angioplasty, and stent placement. It is suitable for use in hospital settings, particularly in catheterization labs. The introducer set is used in patients requiring vascular interventions, including those with peripheral artery disease or requiring embolization of vascular malformations.
Indications for Use
The FDA-cleared indications for this device involve its use in providing vascular access for the delivery of embolization coils and other interventional tools. It is intended for patients undergoing procedures that require precise catheter placement within the vascular system.
Practical Considerations
The introducer set is available in small and large sizes, allowing clinicians to select the appropriate size based on the patient's anatomy and the specific procedure. Compatibility with standard catheters and embolization devices is a key consideration, and proper technique is essential to minimize complications.
Frequently Asked Questions
What is the Creganna Tactx Lotus Introducer Set used for?
It is used for vascular access during interventional procedures, such as the introduction of catheters and embolization coils.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for providing vascular access for the delivery of embolization coils and other interventional tools during 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.