đź“‹ FDA Reference
modification to x-sept transseptal shealth and transition catheter with dilator models pl-12-12-09 pl-12-12-10
Appriva Medical
Summary: The X-Sept Transseptal Sheath is a medical device used for transseptal access in cardiac procedures. It is typically used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K012489 ↗
Decision Date
August 30, 2001
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The X-Sept Transseptal Sheath by Appriva Medical was cleared via the FDA 510(k) pathway on August 30, 2001. It is a Class II device under product code DYB.
What It Is
The X-Sept Transseptal Sheath is a specialized catheter system designed to facilitate transseptal access to the left atrium of the heart. It consists of a sheath, transition catheter, and dilator, allowing for precise navigation through the septum. This device is crucial in procedures requiring left atrial access, such as ablations or mitral valve interventions.
Clinical Applications
This device is commonly used in electrophysiology labs and cardiac catheterization settings. It is essential in procedures like atrial fibrillation ablation, where access to the left atrium is necessary. Cardiologists and electrophysiologists often use it in adult patients undergoing complex cardiac interventions.
Indications for Use
The X-Sept Transseptal Sheath is indicated for use in patients requiring transseptal access to the left atrium, typically for procedures like catheter ablation or other interventions involving the left side of the heart.
Practical Considerations
The device comes in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard electrophysiology lab equipment. Proper technique in handling and insertion is crucial to avoid complications such as cardiac perforation.
Frequently Asked Questions
What is X-Sept Transseptal Sheath used for?
It is used for transseptal access to the left atrium in cardiac procedures.
What specialties typically use this device?
Cardiology and electrophysiology specialties typically use this device.
What are the FDA-cleared indications?
It is indicated for transseptal access in procedures requiring left atrial intervention.
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.