FDA product code QSK: Hybrid Stent Graft, Thoracic Aortic Lesion Treatment
QSK is the FDA product code for hybrid stent graft, thoracic aortic lesion treatment. It is a Class III device, reviewed by the Cardiovascular panel. Devices under QSK reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code.
Definition
Repair or replacement of damaged or diseased vessel of the aortic arch and descending thoracic aorta, with or without involvement of ascending aorta, using vascular grafts and/or stent grafts placed during open surgical repair.
Classification
| Field | Value |
|---|---|
| Device name | Hybrid Stent Graft, Thoracic Aortic Lesion Treatment |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for QSK devices
openFDA lists no recalls for product code QSK.
Frequently asked questions
What is FDA product code QSK?
QSK is the FDA product code for hybrid stent graft, thoracic aortic lesion treatment. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is QSK?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QSK
- Run a recall and safety report across every QSK manufacturer
- Watch product code QSK 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