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

FDA Device Classification

FDA product code SFQ covers "Electrosurgical, Cutting & Coagulation & Accessories, For Cardiac Electrophysiology Device Implantation And Revision", a Class II medical device regulated under 21 CFR 878.4400. Submissions are reviewed by the General, Plastic Surgery panel.

Classification Details

Product Code
SFQ
Device Class
Class II
Regulation Number
878.4400
Submission Type
Review Panel
CV
Medical Specialty
General, Plastic Surgery
Implant
No

Definition

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