Cardiovascular Devices, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Cardiovascular Devices, Inc.” (first 1982, latest 1989), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 89 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 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 |
|---|---|---|---|
| DTY | Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass | 3 | 3 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | 2 |
| CBZ | Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling | 1 | 1 |
| CCE | Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling | 1 | 1 |
| DJY | Ion-Exchange Chromatography | 1 | 1 |
Review panels
- Cardiovascular (5)
- Anesthesiology (2)
- Clinical Toxicology (1)
Most recent Cardiovascular Devices, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K890113 | THE CDI(R) SYSTEM 400 | DJY | 1989-05-23 | 132 |
| K884228 | CDI(R) 2000 BLOOD GAS MONITOR | CBZ | 1989-01-30 | 115 |
| K871221 | CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300 | DRY | 1987-06-05 | 70 |
| K864703 | MODIFIED GAS-STAT(TM) MONITORING SYSTEM | DTY | 1987-02-19 | 79 |
| K843912 | INTRAVASCULAR BLOOD GAS SYSTEM | CCE | 1985-01-10 | 99 |
| K840749 | GAST STAT MONITORING SYSTEM | DTY | 1984-04-17 | 54 |
| K831225 | GAS-STAT MONITORING SYSTEM | DRY | 1983-05-27 | 42 |
| K822000 | EXTRACORPOREAL BLOOD GAS SYSTEM | DTY | 1982-12-22 | 168 |
Recalls
openFDA lists no recalls under a recalling firm named Cardiovascular Devices, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Cardiovascular Systems, Inc. (28 510(k)s)
- Cardiovascular Imaging Systems, Inc. (19 510(k)s)
- Cardiovascular Diagnostics, Inc. (13 510(k)s)
- Cardiovascular Dynamics, Inc. (11 510(k)s)
- Cardiovascular Diagnostic Services (8 510(k)s)
- Cardiovascular Imaging Technologies (4 510(k)s)
- Cardiovascular Imaging Technologies, LLC (3 510(k)s)
- Cardiovascular Research, Inc. (2 510(k)s)
- Cardiovascular Group, Inc. (1 510(k)s)
- Cardiovascular Imaging Solutions , Ltd. (1 510(k)s)
- Cardiovascular Innovations (1 510(k)s)
- Cardiovascular System, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cardiovascular Devices, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Cardiovascular Devices, Inc.” (first 1982, latest 1989), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cardiovascular Devices, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardiovascular Devices, Inc. is 89 days.
Which FDA product codes appear under Cardiovascular Devices, Inc.?
The most frequent FDA product codes under this applicant name are DTY (Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass, 3); DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass, 2); CBZ (Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling, 1).
Next steps
- See all 8 Cardiovascular Devices, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DTY, Cardiovascular Devices, 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.