Cvrx, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Cvrx, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DSR | Stimulator, Carotid Sinus Nerve | 1 | 0 |
Review panels
- Cardiovascular (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P180050 | PMA | BAROSTIM NEO® System | 2019-08-16 |
Recalls
openFDA lists no recalls under a recalling firm named Cvrx, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Cvrx, Inc. is the lead sponsor of 11 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT07232030: Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure (Enrolling by invitation, started 2026-04)
- NCT04502316: Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry) (Active not recruiting, started 2020-06-26)
- NCT02627196: Baroreflex Activation Therapy for Heart Failure (Completed, started 2016-04-19)
- NCT01484288: Baroreflex Activation Therapy in Heart Failure (Completed, started 2011-11)
- NCT01471834: Verification of the Efficacy and Safety of the BAROSTIM NEO System in the Treatment of Drug Resistant Hypertension (Active not recruiting, started 2011-06)
SEC filings
CVRx, Inc. (CVRX): EDGAR filings, CIK 1235912. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Cvrx, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Cvrx, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Cvrx, Inc.?
The most frequent FDA product codes under this applicant name are DSR (Stimulator, Carotid Sinus Nerve, 1).
Next steps
- See all 0 Cvrx, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSR, Cvrx, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.