Product Code: OAD FDA class 3

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

Unknown

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.

510(k)s
0
FEI Numbers
52
Registration Numbers
52
Unique Applicants
0
Years Active

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

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.