510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OAEClass III

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

Unknown
FDA source (opens on fda.gov)

OAE is the FDA product code for Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation, a class III device type. FDA's definition for this code reads: "For the treatment of atrial fibrillation". As of , FDA records hold no 510(k) clearances under this code and 34 recalls.

Classification record

Product code
OAE
Device name
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA definition
For the treatment of atrial fibrillation.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
34

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 49 companies shown, in name order