Cardiac Ablation Percutaneous Catheter
The Cardiac Ablation Percutaneous Catheter is a device used to treat cardiac arrhythmias by delivering energy (such as radiofrequency energy) through a catheter advanced percutaneously to the heart to ablate abnormal electrical pathways. This product code pertains to cardiac ablation catheters indicated for general indications and for the treatment of supraventricular arrhythmias. It is classified as a Class 3 (highest risk) device, requiring Premarket Approval (PMA) prior to marketing. The product code is LPB; no specific regulation number or medical specialty code is recorded, though the review panel is Cardiovascular (CV). No special flags apply to this device.
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Basic Information
- Product Code
- LPB
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
Definition
This product code pertains to cardiac ablation catheters indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (vt). This product code excludes ablation catheters indicated for treatment of atrial flutter [product code oad] and atrial fibrillation [product code oae].
FEI Numbers
This FDA classification entry is associated with 55 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 55 registration numbers. Click on an entry to view related FDA registrations.