📋 FDA Reference
14Fr Low Profile Introducer Kit
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 ?
510(k)
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.
FDA-Cleared Indications
- Facilitates percutaneous access to the vascular system.
- Provides a conduit for the introduction and withdrawal of compatible catheters and other intravascular devices during diagnostic or therapeutic procedures.
Clinical Applications
- Obtaining vascular access for endovascular diagnostic procedures such as angiography.
- Providing access for therapeutic procedures that require insertion of compatible catheters or devices.
- Providing access for embolization procedures when the selected catheter and embolic system are compatible with the introducer.
- Providing access in catheterization laboratories, interventional radiology suites, operating rooms, and other settings where endovascular procedures are performed.
Practical Considerations
- The 14 Fr size is relatively large and requires assessment of vessel caliber, access-site anatomy, and the patient's bleeding risk before use.
- The sheath and dilator should be selected and used with catheters, guidewires, and other devices that are compatible with the kit's inner diameter, length, and specifications.
- Insertion is generally performed using percutaneous vascular access and imaging guidance, commonly ultrasound and fluoroscopy, with local anesthesia and sedation or general anesthesia depending on the procedure.
- The device is for single use unless the FDA labeling specifically states otherwise; it should not be reused or resterilized.
- MRI safety depends on the exact kit and whether any components remain in the patient. The product labeling should be checked before MRI, particularly if a component has not been removed.
Procedures that use this device
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.