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swartz braided transseptal guiding introducer
St Jude Medical
Summary: The Swartz Braided Transseptal Guiding Introducer is a medical device used in cardiac procedures to facilitate access to the left atrium. It is primarily used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K052644 ↗
Decision Date
December 5, 2005
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Swartz Braided Transseptal Guiding Introducer was cleared through the FDA 510k pathway on December 5, 2005. Manufactured by St Jude Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The Swartz Braided Transseptal Guiding Introducer is a specialized catheter designed to assist in transseptal access to the left atrium of the heart. It features a braided design that provides flexibility and support during cardiac procedures. This device is typically used in conjunction with other catheters and sheaths to facilitate the delivery of therapeutic devices or diagnostic tools into the left side of the heart.
Clinical Applications
This device is commonly used in electrophysiology procedures such as atrial fibrillation ablation, where precise access to the left atrium is required. It is also utilized in structural heart interventions, including mitral valve repair or replacement. The introducer is used in hospital settings, primarily in catheterization labs, by cardiologists and electrophysiologists treating adult patients with cardiac arrhythmias or structural heart disease.
Indications for Use
The device is indicated for use in procedures requiring transseptal access to the left atrium. It is suitable for patients undergoing cardiac interventions that necessitate crossing the atrial septum, such as ablation therapies or valve repairs.
Practical Considerations
The Swartz Braided Transseptal Guiding Introducer is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard transseptal needles and sheaths. Clinicians should be familiar with transseptal puncture techniques and the use of fluoroscopy for guidance during procedures.
Frequently Asked Questions
What is Swartz Braided Transseptal Guiding Introducer used for?
It is used for facilitating transseptal access to the left atrium during cardiac procedures such as atrial fibrillation ablation and structural heart interventions.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in catheterization labs during cardiac procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring transseptal access to the left atrium, such as ablation therapies and valve repairs.
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.