FDA product code NPW: Percutaneously Delivered Prostheses And Tricuspid Valves
NPW is the FDA product code for percutaneously delivered prostheses and tricuspid valves. It is a Class III device, reviewed by the Cardiovascular panel. Devices under NPW reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 1 recall for NPW devices, 1 initiated in the last five years.
Definition
These devices are intended to replace a patient's tricuspid heart valve. They are different from the classified device (heart valves) in that they are placed percutaniously and do not require open chest surgery or a cardiotomy for placement.
Classification
| Field | Value |
|---|---|
| Device name | Percutaneously Delivered Prostheses And Tricuspid Valves |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for NPW devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-03-27.
| Year | Recalls |
|---|---|
| 2026 | 1 |
Frequently asked questions
What is FDA product code NPW?
NPW is the FDA product code for percutaneously delivered prostheses and tricuspid valves. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is NPW?
Class III. Typical premarket route: PMA.
Have NPW devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2026-03-27.
Next steps
- Run an FDA pathway report with predicate devices for product code NPW
- Run a recall and safety report across every NPW manufacturer
- Watch product code NPW 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.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times