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arrow transseptal super arrow-flex percutaneous set
Arrow Intl.
Summary: The Arrow Transseptal Super Arrow-Flex Percutaneous Set is a medical device used for transseptal catheterization, primarily by cardiologists. It facilitates access to the left atrium for various cardiac procedures.
FDA Clearance Information
Pathway
510K
Number
K970229 ↗
Decision Date
February 13, 1998
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Arrow Transseptal Super Arrow-Flex Set was cleared via the FDA 510(k) pathway on February 13, 1998. Manufactured by Arrow Intl., it is classified as a Class 2 device under product code DYB.
What It Is
The Arrow Transseptal Super Arrow-Flex Percutaneous Set is designed for transseptal catheterization, a procedure that involves puncturing the septum between the right and left atria of the heart. This device includes a needle and sheath system that allows clinicians to safely and effectively access the left atrium, which is crucial for procedures such as atrial fibrillation ablation and mitral valve interventions.
Clinical Applications
This device is commonly used in electrophysiology labs and cardiac catheterization labs. It is essential for procedures requiring left atrial access, such as pulmonary vein isolation and other complex ablations. Cardiologists and electrophysiologists typically use this device in hospital settings, particularly when treating patients with atrial fibrillation or other structural heart diseases.
Indications for Use
The device is indicated for use in patients requiring transseptal access to the left atrium. It is particularly useful for those undergoing cardiac ablation procedures or other interventions that necessitate crossing the atrial septum.
Practical Considerations
The Arrow Transseptal Super Arrow-Flex Set is available in various sizes to accommodate different patient anatomies. It is compatible with standard electrophysiology catheters and requires careful handling to ensure precise septal puncture. Clinicians should be trained in transseptal techniques to optimize outcomes.
Frequently Asked Questions
What is the Arrow Transseptal Super Arrow-Flex Set used for?
It is used for transseptal catheterization to access the left atrium during cardiac procedures.
What specialties typically use this device?
Cardiologists and electrophysiologists primarily use this device in hospital settings.
What are the FDA-cleared indications?
It is indicated for transseptal access to the left atrium, especially for cardiac ablation procedures.
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.