← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

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

For the treatment of atrial fibrillation.

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
CV
— Implant✓ Life-sustaining— GMP-exempt— Third-party review eligible
6
510(K)/PMA CLEARANCES
pma: 6
0
RECALL ENTRIES

Recent clearances

P130026St Jude Medical · pma2026-06-05
P220013ABBOTT MEDICAL · pma2026-06-05
P220032Boston Scientific Corporation · pma2026-05-29
P100010Medtronic Cryocath, LP · pma2026-04-23
P210027Biosense Webster, Inc. · pma2026-04-17
P200028Medtronic, Inc. · pma2025-10-10

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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