FDA product code NKQ: Guidewire, Catheter, Reprocessed
NKQ is the FDA product code for guidewire, catheter, reprocessed. It is a Class II device, regulated under 21 CFR 870.1330 and reviewed by the Cardiovascular panel. Devices under NKQ reach the market by 510(k); FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for NKQ devices.
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 | Guidewire, Catheter, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 870.1330 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
Recalls for NKQ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-05-04.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code NKQ?
NKQ is the FDA product code for guidewire, catheter, reprocessed. It is a Class II device, regulated under 21 CFR 870.1330 and reviewed by the Cardiovascular panel.
What device class is NKQ?
Class II, regulation 21 CFR 870.1330. Typical premarket route: 510(k).
Have NKQ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2021-05-04.
Next steps
- Run an FDA pathway report with predicate devices for product code NKQ
- Run a recall and safety report across every NKQ manufacturer
- Watch product code NKQ 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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