← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

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

For the treatment of atrial flutter.

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
CV
— Implant✓ Life-sustaining— GMP-exempt— Third-party review eligible
7
510(K)/PMA CLEARANCES
pma: 7
0
RECALL ENTRIES

Recent clearances

P030031Biosense Webster, Inc. · pma2026-07-01
P110016ABBOTT MEDICAL · pma2026-06-05
P040042Irvine Biomedical,Inc.(Ibi) · pma2026-01-15
P060019Irvine Biomedical, Inc. · pma2025-12-19
P150005Boston Scientific Corp · pma2025-12-05
P020025Boston Scientific · pma2025-10-17
P010068Biosense Webster, Inc. · pma2025-02-26

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →