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abiomed 14fr low profile introducer kit
Abiomed
Summary: The Abiomed 14Fr Low Profile Introducer Kit is a medical device used to facilitate the insertion of catheters into blood vessels. It is primarily used by interventional cardiologists and radiologists in procedures requiring vascular access.
FDA Clearance Information
Pathway
510K
Number
K241708 ↗
Decision Date
August 6, 2024
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Abiomed 14Fr Low Profile Introducer Kit was cleared through the FDA 510k pathway on August 6, 2024. Manufactured by Abiomed, it is classified as a Class 2 device under product code DYB.
What It Is
The Abiomed 14Fr Low Profile Introducer Kit is designed to provide a conduit for the insertion of catheters into the vascular system. It features a low-profile design to minimize vessel trauma and improve patient comfort. This device is essential in procedures requiring precise vascular access, such as the placement of embolization coils or other interventional devices.
Clinical Applications
This introducer kit is commonly used in interventional cardiology and radiology settings. It is particularly useful in procedures involving the placement of embolization coils, where precise vascular access is critical. The device is suitable for adult patients requiring interventions that necessitate catheter insertion into large vessels.
Indications for Use
The FDA indications for this device include its use in facilitating vascular access for procedures that require the insertion of catheters. It is intended for patients undergoing interventions that involve the vascular system, such as embolization procedures.
Practical Considerations
The 14Fr size is typical for procedures requiring large bore access, and its low-profile design aids in reducing vessel trauma. Clinicians should ensure compatibility with other devices used in the procedure and be familiar with the insertion technique to optimize outcomes.
Frequently Asked Questions
What is the Abiomed 14Fr Low Profile Introducer Kit used for?
It is used to facilitate the insertion of catheters into blood vessels during interventional procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for facilitating vascular access for catheter insertion in procedures like 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.