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qwikstar diagnostic ablation catheters models d-1229 and d-1230 and qwikstar interface cable model d-1195-12
Biosense Webster
Summary: The QwikStar Diagnostic Ablation Catheters, models D-1229 and D-1230, are used for cardiac ablation procedures to treat arrhythmias. They are primarily utilized by electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
PMA
Number
P990025 ↗
Decision Date
December 18, 2002
Product Code
DRF
Device Class
Class 2
Evidence
0 studies
The QwikStar Diagnostic Ablation Catheters, manufactured by Biosense Webster, received FDA clearance under PMA P990025 on December 18, 2002. They are classified as Class 2 medical devices.
What It Is
The QwikStar Diagnostic Ablation Catheters are specialized tools used in cardiac electrophysiology to deliver radiofrequency energy to specific areas of the heart. This energy creates small scars in the heart tissue to disrupt abnormal electrical pathways, thus treating arrhythmias. The device includes an interface cable and additional location sensors to enhance mapping capabilities, allowing for precise targeting during procedures.
Clinical Applications
These catheters are commonly used in procedures to treat atrial fibrillation, atrial flutter, and other supraventricular tachycardias. They are typically employed in electrophysiology labs within hospitals, where cardiologists and electrophysiologists perform catheter ablation procedures. The device is suitable for adult patients experiencing symptomatic arrhythmias that are refractory to medication.
Indications for Use
The FDA-cleared indications allow the QwikStar catheters to be used in cardiac ablation procedures, specifically for mapping and ablating cardiac tissue to treat arrhythmias. The additional location sensor enhances the precision of these procedures.
Practical Considerations
The QwikStar catheters are designed for compatibility with standard electrophysiology lab equipment. They come in various sizes to accommodate different patient anatomies and are used with a compatible interface cable. Proper technique and familiarity with catheter navigation are essential for effective use.
Frequently Asked Questions
What is QwikStar Diagnostic Ablation Catheters used for?
The QwikStar catheters are used for cardiac ablation procedures to treat arrhythmias by delivering radiofrequency energy to specific heart tissues.
What specialties typically use this device?
Electrophysiologists and cardiologists specializing in cardiac arrhythmias typically use this device in hospital electrophysiology labs.
What are the FDA-cleared indications?
The device is cleared for use in cardiac ablation procedures to map and ablate heart tissue, treating arrhythmias such as atrial fibrillation and flutter.
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.