FDA product code SDZ: Endovascular System For Treatment Of Ascending Aorta And Aortic Arch Lesions
SDZ is the FDA product code for endovascular system for treatment of ascending aorta and aortic arch lesions. It is a Class III device, reviewed by the Cardiovascular panel. Devices under SDZ reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code.
Definition
Endovascular Repair of Ascending Aorta and Aortic Arch Lesions
Classification
| Field | Value |
|---|---|
| Device name | Endovascular System For Treatment Of Ascending Aorta And Aortic Arch Lesions |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for SDZ devices
openFDA lists no recalls for product code SDZ.
Frequently asked questions
What is FDA product code SDZ?
SDZ is the FDA product code for endovascular system for treatment of ascending aorta and aortic arch lesions. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is SDZ?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code SDZ
- Run a recall and safety report across every SDZ manufacturer
- Watch product code SDZ 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.
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