Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
The Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation (product code OAE) is an interventional cardiology catheter used in catheter ablation procedures to treat atrial fibrillation by delivering energy to ablate tissue responsible for the initiation or maintenance of the arrhythmia. It is classified as FDA Class 3, requiring Premarket Approval (PMA), and is reviewed by the Cardiovascular panel. This device carries a life-sustaining flag given its role in treating a serious and potentially debilitating cardiac arrhythmia.
Research product code OAE in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- OAE
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
Definition
For the treatment of atrial fibrillation.
FEI Numbers
This FDA classification entry is associated with 62 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 62 registration numbers. Click on an entry to view related FDA registrations.