FDA product code MZY: Graft, Vascular, Stainless Steel Tunneler
MZY is the FDA product code for graft, vascular, stainless steel tunneler. It is a Class II device, regulated under 21 CFR 870.3450 and reviewed by the Cardiovascular panel. Devices under MZY reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Graft, Vascular, Stainless Steel Tunneler |
| Device class | Class II |
| Regulation | 21 CFR 870.3450 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Recalls for MZY devices
openFDA lists no recalls for product code MZY.
Frequently asked questions
What is FDA product code MZY?
MZY is the FDA product code for graft, vascular, stainless steel tunneler. It is a Class II device, regulated under 21 CFR 870.3450 and reviewed by the Cardiovascular panel.
What device class is MZY?
Class II, regulation 21 CFR 870.3450. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code MZY
- Run a recall and safety report across every MZY manufacturer
- Watch product code MZY 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.