Cardiovascular Dynamics, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Cardiovascular Dynamics, Inc.” (first 1994, latest 1998), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 98 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 |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 6 | 6 |
| ITX | Transducer, Ultrasonic, Diagnostic | 2 | 2 |
| KRA | Catheter, Continuous Flush | 2 | 2 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
Review panels
- Cardiovascular (8)
- Radiology (2)
- General Hospital (1)
Most recent Cardiovascular Dynamics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973713 | 22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR | ITX | 1998-01-23 | 116 |
| K971577 | FOCUS-PV BALLOON DILATATION CATHETER | LIT | 1997-06-18 | 58 |
| K963989 | P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE | ITX | 1997-04-24 | 202 |
| K963688 | FOCUS PV BALLOON DILATATION CATHETER | LIT | 1997-03-28 | 193 |
| K945693 | CVD PERIFLOW(TM) (SMALL VESSEL) BALLOON DILATATION CATHETER | LIT | 1995-08-17 | 269 |
| K952064 | FOCUS BALLOON DILATATION CATHETER | LIT | 1995-06-21 | 50 |
| K951502 | CVD BULLET INFUSION CATYHETER | KRA | 1995-05-10 | 43 |
| K951503 | CVD BULLETT HI-FLO INFUSION CATHETER | KRA | 1995-05-04 | 37 |
| K945465 | CVD SMALL VESSEL BALLOON DILATATION CATHETER | LIT | 1994-12-20 | 43 |
| K944016 | FOCUS BALLOON DILATATION CATHETER | LIT | 1994-12-20 | 126 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cardiovascular Dynamics, 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 Diagnostics, Inc. (13 510(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 Dynamics, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Cardiovascular Dynamics, Inc.” (first 1994, latest 1998), across 4 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 Dynamics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardiovascular Dynamics, Inc. is 98 days.
Which FDA product codes appear under Cardiovascular Dynamics, Inc.?
The most frequent FDA product codes under this applicant name are LIT (Catheter, Angioplasty, Peripheral, Transluminal, 6); ITX (Transducer, Ultrasonic, Diagnostic, 2); KRA (Catheter, Continuous Flush, 2).
Next steps
- See all 11 Cardiovascular Dynamics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LIT, Cardiovascular Dynamics, 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.