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heartport introducer sheath
Heartport
Summary: The Heartport Introducer Sheath is a medical device used to facilitate the introduction of catheters and other devices into the vascular system. It is commonly used by interventional cardiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K972570 ↗
Decision Date
October 1, 1997
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Heartport Introducer Sheath was cleared through the FDA 510(k) pathway on October 1, 1997. It is manufactured by Heartport and classified as a Class 2 device under product code DYB.
What It Is
The Heartport Introducer Sheath is a tubular device designed to provide a conduit for the insertion of catheters and other interventional tools into the vascular system. It is typically made of flexible, biocompatible materials that allow for easy navigation through blood vessels. The sheath helps maintain vascular access and minimizes trauma to the vessel wall during procedures.
Clinical Applications
This device is commonly used in procedures such as angiography, angioplasty, and the deployment of embolization coils. It is utilized in settings like cardiac catheterization labs and interventional radiology suites. The device is suitable for use in adult patients requiring vascular access for diagnostic or therapeutic interventions.
Indications for Use
The FDA indications for the Heartport Introducer Sheath include its use in facilitating the introduction of various catheters and interventional devices into the vascular system. It is intended for patients undergoing procedures that require vascular access.
Practical Considerations
The Heartport Introducer Sheath comes in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with a range of catheters and guidewires. Clinicians should be familiar with the insertion technique to minimize complications such as vessel trauma or bleeding.
Frequently Asked Questions
What is the Heartport Introducer Sheath used for?
It is used to facilitate the introduction of catheters and other devices into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the introduction of catheters and interventional devices into the vascular system for diagnostic and therapeutic procedures.
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.