Product code
QSK: Hybrid stent graft, thoracic aortic lesion treatment
FDA product code · Class III · Cardiovascular
Key facts
| Product code | QSK |
|---|---|
| Device | Hybrid stent graft, thoracic aortic lesion treatment |
| Device class | Class III |
| Review panel | Cardiovascular |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | Yes |
| 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. |
At a glance
- None 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- 1–9 HDE approvals
- 100–999 UDI devices (GUDID)
- 100–999 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database