Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
The Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter (product code OAD) is an interventional cardiology catheter used in catheter ablation procedures to treat atrial flutter by delivering energy to create lesions that interrupt abnormal electrical conduction pathways in the heart. 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 cardiac arrhythmia.
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Basic Information
- Product Code
- OAD
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
Definition
For the treatment of atrial flutter.
FEI Numbers
This FDA classification entry is associated with 52 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 52 registration numbers. Click on an entry to view related FDA registrations.