FDA product code NKO: System, Balloon, Intra-Aortic And Control, Reprocessed
NKO is the FDA product code for system, balloon, intra-aortic and control, reprocessed. It is a Class III device, regulated under 21 CFR 870.3535 and reviewed by the Cardiovascular panel. Devices under NKO reach the market by PMA; 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 | System, Balloon, Intra-Aortic And Control, Reprocessed |
| Device class | Class III |
| Regulation | 21 CFR 870.3535 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | PMA |
Recalls for NKO devices
openFDA lists no recalls for product code NKO.
Frequently asked questions
What is FDA product code NKO?
NKO is the FDA product code for system, balloon, intra-aortic and control, reprocessed. It is a Class III device, regulated under 21 CFR 870.3535 and reviewed by the Cardiovascular panel.
What device class is NKO?
Class III, regulation 21 CFR 870.3535. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code NKO
- Run a recall and safety report across every NKO manufacturer
- Watch product code NKO 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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