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FDA PRODUCT CODE · CLASS III

QZI — Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

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

P230030Farapulse, Inc. · pma2026-07-10
P240013Medtronic, Inc. · pma2026-07-10
P250022ABBOTT MEDICAL · pma2026-07-10
P230017Medtronic, Inc. · pma2026-06-30
P240006Biosense Webster, Inc. · pma2026-06-30
P240044Kardium, Inc. · pma2026-06-23

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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