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FDA PRODUCT CODE · CLASS III

LPB — Cardiac Ablation Percutaneous Catheter

This product code pertains to cardiac ablation catheters indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (vt). This product code excludes ablation catheters indicated for treatment of atrial flutter [product code oad] and atrial fibrillation [product code oae].

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
8
510(K)/PMA CLEARANCES
pma: 8
0
RECALL ENTRIES

Recent clearances

P020045Medtronic Cryocath, LP · pma2026-04-23
P960016St Jude Medical · pma2026-01-15
P240014Stereotaxis, Inc. · pma2026-01-05
P990071Biosense Webster, Inc. · pma2025-12-23
P920047Boston Scientific Corp · pma2025-10-17
P040014Irvine Biomedical, Inc. · pma2025-04-10
P950005Biosense Webster, Inc. · pma2025-02-26
P040036Biosense Webster, Inc. · pma2025-02-25

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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