Advanced Vascular Dynamics: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Advanced Vascular Dynamics” (first 2004, latest 2015), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 90 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 | 2 | 184 |
| 2015 | 1 | 71 |
| 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 |
|---|---|---|---|
| DXC | Clamp, Vascular | 6 | 6 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
Review panels
- Cardiovascular (7)
- General Hospital (1)
Most recent Advanced Vascular Dynamics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151363 | Zephyr Vascular Compression Device | DXC | 2015-07-31 | 71 |
| K142122 | RADAR VASCULAR COMPRESSION DEVICE | DXC | 2014-12-04 | 122 |
| K131571 | AVD RIGHT RADIAL DRAPE | KKX | 2014-01-31 | 246 |
| K093192 | FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE | JOM | 2010-02-12 | 126 |
| K092503 | RADAR VASCULAR COMPRESSION DEVICES | DXC | 2009-11-19 | 97 |
| K090286 | PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE | DXC | 2009-03-23 | 46 |
| K072167 | COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE | DXC | 2007-09-06 | 31 |
| K040615 | COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM | DXC | 2004-06-01 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named Advanced Vascular Dynamics.
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.
- Advanced Cardiovascular Systems, Inc. (103 510(k)s)
- Advanced Surgical Products, Inc. (64 510(k)s)
- Advanced Technology Laboratories, Inc. (61 510(k)s)
- Advanced Sterilization Products (59 510(k)s)
- Advanced Neuromodulation Systems (25 510(k)s)
- Advanced Orthopaedic Solutions, Inc. (24 510(k)s)
- Advanced Biosearch Assn. (22 510(k)s)
- Advanced Biomedical Methods, Inc. (21 510(k)s)
- Advanced Surgical, Inc. (21 510(k)s)
- Advanced Clinical Diagnostics (19 510(k)s)
- Advanced Instrumentations, Inc. (16 510(k)s)
- Advanced Instruments, Inc. (16 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Advanced Vascular Dynamics?
FDA lists 8 510(k) clearances under the applicant name “Advanced Vascular Dynamics” (first 2004, latest 2015), across 3 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 Advanced Vascular Dynamics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Advanced Vascular Dynamics is 90 days.
Which FDA product codes appear under Advanced Vascular Dynamics?
The most frequent FDA product codes under this applicant name are DXC (Clamp, Vascular, 6); JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic, 1); KKX (Drape, Surgical, Antimicrobial, 1).
Next steps
- See all 8 Advanced Vascular Dynamics clearances with predicates and recalls
- Run predicate analysis for product code DXC, Advanced Vascular Dynamics'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.