FDA product code DSR: Stimulator, Carotid Sinus Nerve
DSR is the FDA product code for stimulator, carotid sinus nerve. It is a Class III device, regulated under 21 CFR 870.3850 and reviewed by the Cardiovascular panel. Devices under DSR reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Call for PMAs 12/26/96 (61 FR 50706 (9/27/96))
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Carotid Sinus Nerve |
| Device class | Class III |
| Regulation | 21 CFR 870.3850 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | PMA |
| Implant | Yes |
Recalls for DSR devices
openFDA lists no recalls for product code DSR.
Frequently asked questions
What is FDA product code DSR?
DSR is the FDA product code for stimulator, carotid sinus nerve. It is a Class III device, regulated under 21 CFR 870.3850 and reviewed by the Cardiovascular panel.
What device class is DSR?
Class III, regulation 21 CFR 870.3850. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code DSR
- Run a recall and safety report across every DSR manufacturer
- Watch product code DSR 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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