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fast-cath transseptal catheter introducer
Daig
Summary: The Fast-Cath Transseptal Catheter Introducer by Daig is a medical device used to facilitate transseptal access to the left atrium. It is primarily used by cardiologists during electrophysiological procedures.
FDA Clearance Information
Pathway
510K
Number
K964518 ↗
Decision Date
May 14, 1997
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Fast-Cath Transseptal Catheter Introducer was cleared through the FDA 510k pathway on May 14, 1997. Manufactured by Daig, it is classified as a Class 2 medical device.
What It Is
The Fast-Cath Transseptal Catheter Introducer is a specialized catheter introducer designed to enable transseptal access to the left atrium. It is typically used in conjunction with other catheters during procedures that require access to the left side of the heart, such as ablations or other electrophysiological interventions. The device facilitates safe and effective puncture of the atrial septum, allowing for the passage of diagnostic or therapeutic catheters.
Clinical Applications
This device is commonly used in electrophysiology labs during procedures such as atrial fibrillation ablation, where access to the left atrium is necessary. Cardiologists and electrophysiologists frequently use it in hospital settings, particularly in patients with arrhythmias requiring intervention. It is essential in cases where precise transseptal puncture is critical for the success of the procedure.
Indications for Use
The Fast-Cath Transseptal Catheter Introducer is indicated for patients requiring transseptal access to the left atrium, often in the context of electrophysiological studies or interventions. It is suitable for individuals undergoing procedures like atrial fibrillation ablation.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard electrophysiological catheters and requires careful handling to ensure accurate transseptal puncture. Clinicians should be trained in transseptal techniques to use this device effectively.
Frequently Asked Questions
What is the Fast-Cath Transseptal Catheter Introducer used for?
It is used to facilitate transseptal access to the left atrium during electrophysiological procedures.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for transseptal access to the left atrium, often in the context of electrophysiological studies or 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.