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abiomed 14fr low profile introducer set
Abiomed
Summary: The Abiomed 14Fr Low Profile Introducer Set is a medical device used primarily for vascular access in procedures involving embolization coils. It is commonly utilized by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K222113 ↗
Decision Date
October 13, 2022
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Abiomed 14Fr Low Profile Introducer Set was cleared through the FDA 510(k) pathway on October 13, 2022. Manufactured by Abiomed, it is classified as a Class 2 device under product code DYB.
What It Is
The Abiomed 14Fr Low Profile Introducer Set is a vascular access device designed to facilitate the insertion of embolization coils and other interventional tools. It features a low-profile design that minimizes trauma to the vessel and allows for smoother navigation within the vascular system. This device is essential for procedures requiring precise placement of therapeutic devices within blood vessels.
Clinical Applications
This introducer set is commonly used in interventional cardiology and radiology for procedures involving the placement of embolization coils to treat aneurysms or vascular malformations. It is particularly useful in settings where minimally invasive techniques are preferred, such as in catheterization labs or interventional suites. The device is suitable for adult patients requiring vascular interventions.
Indications for Use
The FDA-cleared indications for this device include its use in procedures requiring vascular access for the delivery of embolization coils. It is intended for patients with conditions that necessitate the occlusion of blood vessels, such as aneurysms or arteriovenous malformations.
Practical Considerations
The Abiomed 14Fr Low Profile Introducer Set is typically available in various lengths to accommodate different patient anatomies. It is compatible with a range of embolization coils and other interventional devices. Clinicians should be familiar with the technique of vascular access and the specific requirements of the procedure being performed.
Frequently Asked Questions
What is the Abiomed 14Fr Low Profile Introducer Set used for?
It is used for vascular access in procedures involving the delivery of embolization coils to treat conditions like aneurysms.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in vascular access procedures requiring the placement of embolization coils.
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.