Cardiovascular Diagnostic Services: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Cardiovascular Diagnostic Services” (first 1981, latest 1996), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 78 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 |
|---|---|---|---|
| GJS | Test, Time, Prothrombin | 4 | 4 |
| GFO | Activated Partial Thromboplastin | 1 | 1 |
| GKP | Instrument, Coagulation, Automated | 1 | 1 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 1 | 1 |
| MAV | Syringe, Balloon Inflation | 1 | 1 |
Review panels
- Hematology (7)
- Cardiovascular (1)
Most recent Cardiovascular Diagnostic Services 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955843 | TAS PTONE | GJS | 1996-03-18 | 83 |
| K933092 | TAS ANALYZER | GKP | 1993-11-15 | 144 |
| K904325 | COAG-1 PT-NC TEST CARD | GJS | 1991-01-25 | 127 |
| K903019 | MODIFIED COAG-1 PT TEST CARD | GJS | 1990-08-01 | 21 |
| K891015 | COAG-1 APTT TEST CARD | GFO | 1989-05-22 | 83 |
| K882456 | COAG-I PT TEST CARD | GJS | 1988-08-25 | 72 |
| K882444 | COAG-I ANALYZER, ALPHA MODEL | JPA | 1988-08-25 | 72 |
| K812304 | DORROS-SPRING PRESSURIZER | MAV | 1981-10-13 | 56 |
Recalls
openFDA lists no recalls under a recalling firm named Cardiovascular Diagnostic Services.
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. (26 510(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 Devices, Inc. (8 510(k)s)
- Cardiovascular Imaging Technologies (7 510(k)s)
- Cardiovascular Research, Inc. (2 510(k)s)
- Cardiovascular Systems Incorporated (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 Diagnostic Services?
FDA lists 8 510(k) clearances under the applicant name “Cardiovascular Diagnostic Services” (first 1981, latest 1996), across 5 product codes in 2 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 Diagnostic Services?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardiovascular Diagnostic Services is 78 days.
Which FDA product codes appear under Cardiovascular Diagnostic Services?
The most frequent FDA product codes under this applicant name are GJS (Test, Time, Prothrombin, 4); GFO (Activated Partial Thromboplastin, 1); GKP (Instrument, Coagulation, Automated, 1).
Next steps
- See all 8 Cardiovascular Diagnostic Services clearances with predicates and recalls
- Run predicate analysis for product code GJS, Cardiovascular Diagnostic Services'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.