FDA product code SFQ: Electrosurgical, Cutting & Coagulation & Accessories, For Cardiac Electrophysiology Device Implantation And Revision
SFQ is the FDA product code for electrosurgical, cutting & coagulation & accessories, for cardiac electrophysiology device implantation and revision. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the Cardiovascular panel. Devices under SFQ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Surgical device used to dissect cardiac tissue for the implantation and revision of cardiac electrophysiology leads
Classification
| Field | Value |
|---|---|
| Device name | Electrosurgical, Cutting & Coagulation & Accessories, For Cardiac Electrophysiology Device Implantation And Revision |
| Device class | Class II |
| Regulation | 21 CFR 878.4400 |
| Review panel | CV — Cardiovascular |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
Recalls for SFQ devices
openFDA lists no recalls for product code SFQ.
Frequently asked questions
What is FDA product code SFQ?
SFQ is the FDA product code for electrosurgical, cutting & coagulation & accessories, for cardiac electrophysiology device implantation and revision. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the Cardiovascular panel.
What device class is SFQ?
Class II, regulation 21 CFR 878.4400. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SFQ
- Run a recall and safety report across every SFQ manufacturer
- Watch product code SFQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.