đź“‹ FDA Reference
daig fast cath transseptal sheath introducer
Daig
Summary: The Daig Fast Cath Transseptal Sheath Introducer is a medical device used to facilitate access to the left atrium of the heart during procedures such as catheter ablation. It is primarily used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K920327 ↗
Decision Date
April 16, 1992
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Daig Fast Cath Transseptal Sheath Introducer was cleared through the FDA 510(k) pathway on April 16, 1992. Manufactured by Daig, it is classified as a Class 2 device under product code DYB.
What It Is
The Daig Fast Cath Transseptal Sheath Introducer is a specialized catheter sheath designed to enable transseptal access to the left atrium. It is used in conjunction with a transseptal needle to puncture the interatrial septum, allowing for the passage of diagnostic or therapeutic catheters. This device is essential in procedures requiring precise access to the left side of the heart.
Clinical Applications
This device is commonly used in electrophysiology labs during procedures such as catheter ablation for atrial fibrillation or flutter. It is also used in structural heart interventions like mitral valve repair or replacement. The primary users are cardiologists and electrophysiologists working in hospital settings, particularly in patients with arrhythmias or structural heart disease.
Indications for Use
The FDA indications for the Daig Fast Cath Transseptal Sheath Introducer include facilitating transseptal access to the left atrium. It is indicated for patients undergoing procedures that require entry into the left atrium, such as ablation or valve interventions.
Practical Considerations
The Daig Fast Cath Transseptal Sheath Introducer comes in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard transseptal needles and guidewires. Clinicians should be skilled in transseptal puncture techniques to use this device effectively.
Frequently Asked Questions
What is the Daig Fast Cath Transseptal Sheath Introducer used for?
It is used to facilitate transseptal access to the left atrium during cardiac procedures such as catheter ablation and valve interventions.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device, especially in electrophysiology labs and during structural heart procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating transseptal access to the left atrium, particularly in procedures requiring entry into the left side of the heart.
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.