đź“‹ FDA Reference
daig fast cath tm transseptal sheath introducer
Diag
Summary: The daig fast cath tm transseptal sheath introducer is a medical device used for transseptal catheterization procedures. It is primarily utilized by cardiologists and electrophysiologists to access the left atrium of the heart.
FDA Clearance Information
Pathway
510K
Number
K911883 ↗
Decision Date
November 29, 1991
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The daig fast cath tm transseptal sheath introducer was cleared through the FDA 510(k) pathway on November 29, 1991. It is manufactured by Diag and classified as a Class 2 medical device.
What It Is
The daig fast cath tm transseptal sheath introducer is a specialized catheter sheath designed to facilitate transseptal access to the left atrium of the heart. It is used in procedures that require crossing the atrial septum, such as atrial fibrillation ablations or mitral valve repairs. The sheath provides a stable and safe conduit for other catheters and devices to pass through the septum.
Clinical Applications
This device is commonly used in interventional cardiology and electrophysiology. It is essential in procedures like atrial fibrillation ablation, left atrial appendage closure, and mitral valve interventions. The device is typically used in hospital settings, particularly in cardiac catheterization labs, and is suitable for adult patients requiring transseptal access.
Indications for Use
The FDA-cleared indications for this device involve procedures requiring access to the left atrium via the transseptal approach. It is used in patients needing interventions on the left side of the heart, such as those with atrial fibrillation or structural heart disease.
Practical Considerations
The daig fast cath tm transseptal sheath introducer is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard transseptal needles and guidewires. Clinicians should be trained in transseptal puncture techniques to ensure safe and effective use.
Frequently Asked Questions
What is daig fast cath tm transseptal sheath introducer used for?
It is used for transseptal catheterization procedures to access the left atrium of the heart.
What specialties typically use this device?
Cardiology and electrophysiology specialists typically use this device.
What are the FDA-cleared indications?
The device is indicated for procedures requiring transseptal access to the left atrium, such as atrial fibrillation ablation and mitral valve interventions.
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.