FDA product code DYE: Replacement Heart-Valve
DYE is the FDA product code for replacement heart-valve. It is a Class III device, regulated under 21 CFR 870.3925 and reviewed by the Cardiovascular panel. Devices under DYE reach the market by PMA; FDA lists no cleared 510(k)s for it. 9 PMA applications cite this product code. FDA has posted 8 recalls for DYE devices.
Definition
Call for pmas to be filed by 12/9/87 (52 fr 23137 (6/17/87))
Classification
| Field | Value |
|---|---|
| Device name | Replacement Heart-Valve |
| Device class | Class III |
| Regulation | 21 CFR 870.3925 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | PMA |
| Implant | Yes |
Recalls for DYE devices
8 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-05-21.
| Year | Recalls |
|---|---|
| 2019 | 5 |
Frequently asked questions
What is FDA product code DYE?
DYE is the FDA product code for replacement heart-valve. It is a Class III device, regulated under 21 CFR 870.3925 and reviewed by the Cardiovascular panel.
What device class is DYE?
Class III, regulation 21 CFR 870.3925. Typical premarket route: PMA.
Have DYE devices been recalled?
Yes: 8 product recalls across 3 recall events; the most recent began 2019-05-21.
Next steps
- Run an FDA pathway report with predicate devices for product code DYE
- Run a recall and safety report across every DYE manufacturer
- Watch product code DYE 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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