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FDA PRODUCT CODE · CLASS II

SFQ — Electrosurgical, Cutting & Coagulation & Accessories, For Cardiac Electrophysiology Device Implantation And Revision

Surgical device used to dissect cardiac tissue for the implantation and revision of cardiac electrophysiology leads

DEVICE CLASS
Class II
REGULATION
21 CFR 878.4400
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

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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