FDA product code QMG: Shockwave Intravascular Lithotripsy System
QMG is the FDA product code for shockwave intravascular lithotripsy system. It is a Class III device, reviewed by the Cardiovascular panel. Devices under QMG reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Dilatation of coronary arteries prior to stenting
Classification
| Field | Value |
|---|---|
| Device name | Shockwave Intravascular Lithotripsy System |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QMG devices
openFDA lists no recalls for product code QMG.
Frequently asked questions
What is FDA product code QMG?
QMG is the FDA product code for shockwave intravascular lithotripsy system. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is QMG?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QMG
- Run a recall and safety report across every QMG manufacturer
- Watch product code QMG 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.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times