FDA product code NKT: Injector And Syringe, Angiographic, Reprocessed
NKT is the FDA product code for injector and syringe, angiographic, reprocessed. It is a Class II device, regulated under 21 CFR 870.1650 and reviewed by the General Hospital panel. Devices under NKT reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Injector And Syringe, Angiographic, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 870.1650 |
| Review panel | HO — General Hospital |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NKT devices
openFDA lists no recalls for product code NKT.
Frequently asked questions
What is FDA product code NKT?
NKT is the FDA product code for injector and syringe, angiographic, reprocessed. It is a Class II device, regulated under 21 CFR 870.1650 and reviewed by the General Hospital panel.
What device class is NKT?
Class II, regulation 21 CFR 870.1650. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NKT
- Run a recall and safety report across every NKT manufacturer
- Watch product code NKT 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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