FDA product code SHR: Device For Open Surgical Explant Of Endovascular Prostheses
SHR is the FDA product code for device for open surgical explant of endovascular prostheses. It is a Class II device, regulated under 21 CFR 870.4520 and reviewed by the Cardiovascular panel. Devices under SHR reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
This device is a non-implantable mechanical surgical tool to aid in the open surgical removal of endovascular prostheses in blood vessels.
Classification
| Field | Value |
|---|---|
| Device name | Device For Open Surgical Explant Of Endovascular Prostheses |
| Device class | Class II |
| Regulation | 21 CFR 870.4520 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
Recalls for SHR devices
openFDA lists no recalls for product code SHR.
Frequently asked questions
What is FDA product code SHR?
SHR is the FDA product code for device for open surgical explant of endovascular prostheses. It is a Class II device, regulated under 21 CFR 870.4520 and reviewed by the Cardiovascular panel.
What device class is SHR?
Class II, regulation 21 CFR 870.4520. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SHR
- Run a recall and safety report across every SHR manufacturer
- Watch product code SHR 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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