FDA product code DSW: Bag, Polymeric Mesh, Pacemaker
DSW is the FDA product code for bag, polymeric mesh, pacemaker. It is a Class I device, regulated under 21 CFR 870.3650 and reviewed by the Cardiovascular panel. Devices under DSW reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Bag, Polymeric Mesh, Pacemaker |
| Device class | Class I |
| Regulation | 21 CFR 870.3650 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
| Implant | Yes |
Recalls for DSW devices
openFDA lists no recalls for product code DSW.
Frequently asked questions
What is FDA product code DSW?
DSW is the FDA product code for bag, polymeric mesh, pacemaker. It is a Class I device, regulated under 21 CFR 870.3650 and reviewed by the Cardiovascular panel.
What device class is DSW?
Class I, regulation 21 CFR 870.3650. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code DSW
- Run a recall and safety report across every DSW manufacturer
- Watch product code DSW 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.