Cardiovascular Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Cardiovascular Diagnostics, Inc.” (first 1995, latest 2002), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 88 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 |
|---|---|---|---|
| GGN | Plasma, Coagulation Control | 5 | 5 |
| KFF | Assay, Heparin | 2 | 2 |
| GIZ | Plasma, Control, Normal | 1 | 1 |
| GJS | Test, Time, Prothrombin | 1 | 1 |
| GKP | Instrument, Coagulation, Automated | 1 | 1 |
| JBP | Activated Whole Blood Clotting Time | 1 | 1 |
| JOX | Analyzer, Heparin, Automated | 1 | 1 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 1 | 1 |
Review panels
- Hematology (13)
Most recent Cardiovascular Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K013305 | ENOXAPARIN TEST CARD | KFF | 2002-08-23 | 323 |
| K994194 | (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT | JBP | 2000-03-28 | 106 |
| K994159 | HMP CONTROLS (TAS) RAPIDPOINT | GGN | 2000-02-15 | 68 |
| K993519 | RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST | JOX | 2000-01-14 | 88 |
| K990566 | TAS ANALYZER, MODEL 1009 | JPA | 1999-05-14 | 81 |
| K981206 | TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS) | GKP | 1998-05-26 | 55 |
| K981178 | THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS | GGN | 1998-04-27 | 26 |
| K971748 | TAS PT-NCTEST CONTROLS | GGN | 1997-05-29 | 17 |
| K961814 | THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS | GIZ | 1996-08-13 | 95 |
| K961189 | TAS A PTT TEST CONTROLS | GGN | 1996-06-05 | 71 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cardiovascular Diagnostics, 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. (26 510(k)s)
- Cardiovascular Imaging Systems, Inc. (19 510(k)s)
- Cardiovascular Dynamics, Inc. (11 510(k)s)
- Cardiovascular Devices, Inc. (8 510(k)s)
- Cardiovascular Diagnostic Services (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 Diagnostics, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Cardiovascular Diagnostics, Inc.” (first 1995, latest 2002), across 8 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 Cardiovascular Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardiovascular Diagnostics, Inc. is 88 days.
Which FDA product codes appear under Cardiovascular Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are GGN (Plasma, Coagulation Control, 5); KFF (Assay, Heparin, 2); GIZ (Plasma, Control, Normal, 1).
Next steps
- See all 13 Cardiovascular Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GGN, Cardiovascular Diagnostics, 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, 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.