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14fr low profile introducer kit
Abiomed
Summary: The 14fr low profile introducer kit by Abiomed is a medical device used for vascular access, primarily in interventional radiology and cardiology. It is utilized by clinicians to facilitate the insertion of catheters or other devices into the vascular system.
FDA Clearance Information
Pathway
510K
Number
K252766 ↗
Decision Date
October 8, 2025
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510k pathway on October 8, 2025, and is manufactured by Abiomed. It is classified as a Class 2 device under product code DYB.
What It Is
The 14fr low profile introducer kit is a medical device designed to provide vascular access for the insertion of catheters or other medical instruments. It features a low-profile design to minimize trauma to the vessel and improve patient comfort. The introducer kit typically includes a sheath and dilator, allowing for smooth insertion and removal during procedures.
Clinical Applications
Commonly used in interventional radiology and cardiology, this device is essential for procedures requiring vascular access, such as embolization, angiography, or placement of stents. It is suitable for use in hospital settings, particularly in catheterization labs or operating rooms, and is used for adult and pediatric patients requiring vascular interventions.
Indications for Use
The FDA-cleared indications for this device involve facilitating access to the vascular system for diagnostic or therapeutic procedures. It is intended for patients requiring interventions such as embolization, where precise vascular access is critical.
Practical Considerations
The 14fr size is typical for adult patients, providing a balance between ease of access and minimizing vessel trauma. Compatibility with a range of catheters and devices is a key feature, and clinicians should be familiar with standard insertion techniques to optimize outcomes.
Frequently Asked Questions
What is the 14fr low profile introducer kit used for?
It is used to provide vascular access for the insertion of catheters or other devices during interventional procedures.
What specialties typically use this device?
Interventional radiology and cardiology are the primary specialties using this device.
What are the FDA-cleared indications?
The device is indicated for facilitating vascular access for diagnostic or therapeutic procedures, such as embolization.
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.