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abiomed 23 fr sheath
Abiomed
Summary: The Abiomed 23 Fr Sheath is a medical device used primarily in interventional cardiology for vascular access. It is utilized by cardiologists and interventional radiologists during procedures requiring large-bore access.
FDA Clearance Information
Pathway 510K
Number K201116 ↗
Decision Date June 15, 2020
Product Code DYB
Device Class Class 2
Evidence 0 studies
The Abiomed 23 Fr Sheath was cleared through the FDA 510(k) pathway on June 15, 2020. It is manufactured by Abiomed and classified as a Class 2 device under product code DYB.
What It Is
The Abiomed 23 Fr Sheath is a large-bore vascular access device designed to facilitate the introduction of catheters and other interventional tools into the vascular system. It is typically used in procedures that require robust access to large vessels, such as those involving mechanical circulatory support devices. The sheath is engineered to minimize trauma to the vessel and ensure smooth passage of instruments.
Clinical Applications
This device is commonly used in interventional cardiology and vascular surgery settings, particularly during procedures like the insertion of Impella heart pumps or other large-bore catheters. It is essential in settings where rapid and reliable vascular access is critical, such as in cardiac catheterization labs or during emergency interventions. The sheath is suitable for adult patients requiring large-bore access, often those undergoing complex cardiac procedures.
Indications for Use
The FDA indications suggest the sheath is intended for use in procedures requiring large-bore vascular access. This typically involves patients who need mechanical circulatory support or other interventions that necessitate the passage of large devices through the vasculature.
Practical Considerations
The 23 Fr size indicates a large diameter, suitable for procedures involving substantial devices. Clinicians should ensure compatibility with the intended catheters and consider vessel size and patient anatomy when selecting this sheath. Proper technique is crucial to minimize vascular trauma and ensure successful access.
Frequently Asked Questions
What is the Abiomed 23 Fr Sheath used for?
It is used for large-bore vascular access in procedures like the insertion of mechanical circulatory support devices.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The sheath is indicated for use in procedures requiring large-bore vascular access, such as those involving mechanical circulatory support.
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.