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morph dna steerable introducer sheath
Biocardia
Summary: The Morph DNA Steerable Introducer Sheath by Biocardia is a medical device used in interventional procedures to facilitate the introduction of catheters and other devices. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K242169 ↗
Decision Date
August 23, 2024
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Morph DNA Steerable Introducer Sheath was cleared through the FDA 510(k) pathway on August 23, 2024. It is manufactured by Biocardia and classified as a Class 2 device under product code DYB.
What It Is
The Morph DNA Steerable Introducer Sheath is a specialized medical device designed to provide a flexible and steerable pathway for the insertion of catheters and other interventional tools into the vascular system. Its steerable design allows for precise navigation through complex vascular anatomy, enhancing the safety and efficacy of procedures. This device is particularly useful in procedures requiring high precision and control.
Clinical Applications
Commonly used in interventional cardiology and radiology, this device is employed during procedures such as embolization, where precise delivery of coils or other embolic materials is necessary. It is suitable for use in both hospital and outpatient settings, and is often utilized in patients with complex vascular conditions requiring targeted intervention.
Indications for Use
The FDA indications for the Morph DNA Steerable Introducer Sheath include its use in facilitating the introduction of catheters and other devices into the vascular system. It is intended for patients requiring interventional procedures that demand precise navigation and control.
Practical Considerations
The Morph DNA Steerable Introducer Sheath is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and interventional tools, and clinicians should be familiar with its steerable mechanism to maximize its utility during procedures.
Frequently Asked Questions
What is the Morph DNA Steerable Introducer Sheath used for?
It is used to facilitate the introduction of catheters and other interventional devices into the vascular system, particularly in procedures requiring precise navigation.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use this device during vascular procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction of catheters and other devices into the vascular system for interventional 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.