FDA product code MWH: Pulmonic Valved Conduit
MWH is the FDA product code for pulmonic valved conduit. It is a HDE device, reviewed by the Cardiovascular panel. Devices under MWH reach the market by Unclassified; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for MWH devices.
Classification
| Field | Value |
|---|---|
| Device name | Pulmonic Valved Conduit |
| Device class | HDE |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for MWH devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2006-01-18.
Frequently asked questions
What is FDA product code MWH?
MWH is the FDA product code for pulmonic valved conduit. It is a HDE device, reviewed by the Cardiovascular panel.
What device class is MWH?
HDE. Typical premarket route: Unclassified.
Have MWH devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2006-01-18.
Next steps
- Run an FDA pathway report with predicate devices for product code MWH
- Run a recall and safety report across every MWH manufacturer
- Watch product code MWH 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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