Cardiovascular Imaging Systems, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Cardiovascular Imaging Systems, Inc.” (first 1989, latest 1997), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 91 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 |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | 8 | 8 |
| ITX | Transducer, Ultrasonic, Diagnostic | 6 | 6 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | 2 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| DXK | Echocardiograph | 1 | 1 |
| LYK | Angioscope | 1 | 1 |
Review panels
- Cardiovascular (11)
- Radiology (8)
Most recent Cardiovascular Imaging Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970049 | BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/ | ITX | 1997-06-20 | 165 |
| K942231 | MICROVIEW II/MICRORAIL II CATHETERS | DQO | 1994-08-01 | 87 |
| K933517 | AUTOMATIC PULL BACK DEVICE | DQX | 1993-10-15 | 87 |
| K930232 | CVIS INSIGHT IMAGING GUIDE CATHETER | DQO | 1993-07-21 | 183 |
| K924922 | CVIS INSIGHT IMAGING CATHETER | DQO | 1993-06-29 | 330 |
| K930311 | CVIS LONGVIEW | DQO | 1993-06-02 | 132 |
| K921879 | CBIS CATHETER PULL-BACK DEVICE | DQO | 1992-07-16 | 87 |
| K921750 | CVIS INSIGHT III SYSTEM | ITX | 1992-07-13 | 91 |
| K921631 | CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL | ITX | 1992-07-02 | 87 |
| K921148 | CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE | ITX | 1992-06-16 | 97 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cardiovascular Imaging Systems, 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 Diagnostics, Inc. (13 510(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 (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 Imaging Systems, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Cardiovascular Imaging Systems, Inc.” (first 1989, latest 1997), across 6 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 Imaging Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardiovascular Imaging Systems, Inc. is 91 days.
Which FDA product codes appear under Cardiovascular Imaging Systems, Inc.?
The most frequent FDA product codes under this applicant name are DQO (Catheter, Intravascular, Diagnostic, 8); ITX (Transducer, Ultrasonic, Diagnostic, 6); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 2).
Next steps
- See all 19 Cardiovascular Imaging Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQO, Cardiovascular Imaging Systems, 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.