Corventis, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Corventis, Inc.” (first 2009, latest 2014), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 65 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 88 |
| 2013 | 0 | — |
| 2014 | 1 | 65 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QYX | Outpatient Cardiac Telemetry | 4 | 4 |
| DSI | Detector And Alarm, Arrhythmia | 2 | 2 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 1 | 1 |
Review panels
- Cardiovascular (7)
Most recent Corventis, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133701 | NUVANT MCT SYSTEM | QYX | 2014-02-06 | 65 |
| K113372 | NUVANT, MOBILC CARDIAC TELEMETRY | QYX | 2012-03-07 | 112 |
| K113187 | AVIVO MOBILE PATIENT MANAGEMENT | MHX | 2012-01-04 | 65 |
| K111917 | NUVANT, MOBILE CARDIAC TELEMETRY | QYX | 2011-08-24 | 49 |
| K091971 | AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM | DSI | 2009-08-27 | 57 |
| K090696 | NUVANT CARDIAC EVENT MONITORING SYSTEM; NUVANT MOBILE CARDIAC TELEMETRY SYSTEM | QYX | 2009-06-19 | 95 |
| K083287 | AVIVO MOBILE PATIENT MANAGEMENT SYSTEM | DSI | 2009-02-03 | 88 |
Recalls
openFDA lists no recalls under a recalling firm named Corventis, 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 Corventis, Inc. is the lead sponsor of 5 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00919087: Non Invasive Arrhythmia Detection in Hospital Settings (Completed, started 2009-04)
- NCT00919828: Monitor Patients With Acute Heart Failure (Completed, started 2009-03)
- NCT00918502: Monitor Patients With Sleep Apnea (Completed, started 2009-03)
- NCT00919438: Non Invasive External Monitoring in Dialysis Patients (Completed, started 2009-01)
- NCT00557804: Monitoring in Congestive Heart Failure Study (Completed, started 2007-12)
Frequently asked questions
How many FDA 510(k) clearances are listed under Corventis, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Corventis, Inc.” (first 2009, latest 2014), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Corventis, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Corventis, Inc. is 65 days.
Which FDA product codes appear under Corventis, Inc.?
The most frequent FDA product codes under this applicant name are QYX (Outpatient Cardiac Telemetry, 4); DSI (Detector And Alarm, Arrhythmia, 2); MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 1).
Next steps
- See all 7 Corventis, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QYX, Corventis, 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.