DSR · Stimulator, Carotid Sinus Nerve
Cardiovascular · 21 CFR 870.3850 · Class 3
Overview
| Product Code | DSR |
|---|---|
| Device Name | Stimulator, Carotid Sinus Nerve |
| Regulation | 21 CFR 870.3850 |
| Device Class | Class 3 |
| Review Panel | Cardiovascular |
| Implant | Yes |
Identification
A carotid sinus nerve stimulator is an implantable device used to decrease arterial pressure by stimulating Hering's nerve at the carotid sinus.
Classification Rationale
Class III (premarket approval).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P180050 | BAROSTIM NEO® System | Cvrx, Inc. | Aug 16, 2019 | APPR |
Top Applicants
- Cvrx, Inc. — 1 clearance
