Applied Vascular Devices, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Applied Vascular Devices, Inc.” (first 1988, latest 1991), across 13 product codes in 5 review panels. Median 510(k) review time under this name: 87 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 |
|---|---|---|---|
| DXC | Clamp, Vascular | 5 | 5 |
| DXE | Catheter, Embolectomy | 2 | 2 |
| DYB | Introducer, Catheter | 2 | 2 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 2 | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| DQT | Occluder, Catheter Tip | 1 | 1 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| DSS | Clip, Vascular | 1 | 1 |
| DXT | Injector And Syringe, Angiographic | 1 | 1 |
Plus 3 more product codes.
Review panels
- Cardiovascular (13)
- Gastroenterology and Urology (3)
- General and Plastic Surgery (3)
- General Hospital (1)
- Obstetrics and Gynecology (1)
Most recent Applied Vascular Devices, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K911730 | SURGICAL OBTURATOR WITH SEAL | GCJ | 1991-12-23 | 250 |
| K911589 | DISPOSABLE SURGICAL TROCAR WITH SEAL | GCJ | 1991-07-05 | 87 |
| K910339 | AVD INTIMAX OCCLUSION CATHETER | DQT | 1991-05-29 | 121 |
| K910372 | INTIMAX THROMBECTOMY CATHETER | DXE | 1991-04-26 | 87 |
| K911181 | INTIMAX(TM) IRRIGATION CATHETER | GCA | 1991-04-18 | 31 |
| K910493 | AVD INTIMAX CHOLANGIOGRAPHY CATHETER | FGE | 1991-03-28 | 51 |
| K903848 | DIAGNOSTIC INTRASCULAR CATHETER | DQO | 1991-03-25 | 216 |
| K905738 | OPERATIVE CHOLANGIOGRAPHIC CATHETER | FGE | 1991-03-21 | 87 |
| K910079 | DISPOSABLE INTRODUCER SHEATH | KDC | 1991-02-27 | 50 |
| K902256 | IRRIGATION CATHETER 4, 6 AND 10 FRENCH | DQY | 1991-02-15 | 270 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Applied Vascular Devices, 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.
- Applied Medical Resources (115 510(k)s)
- Applied Medical Technology, Inc. (25 510(k)s)
- Applied Medical Technologies (24 510(k)s)
- Applied Medical Research (22 510(k)s)
- Applied Osteo Systems, Inc. (15 510(k)s)
- Applied Medical (14 510(k)s)
- Applied Urology, Inc. (13 510(k)s)
- Applied Medical Devices, Inc. (11 510(k)s)
- Applied Laboratories, Inc. (9 510(k)s)
- Applied Biomaterial Technologies (7 510(k)s)
- Applied Imaging Corp. (7 510(k)s)
- Applied Polytechnology, Inc. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Applied Vascular Devices, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Applied Vascular Devices, Inc.” (first 1988, latest 1991), across 13 product codes in 5 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 Applied Vascular Devices, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Applied Vascular Devices, Inc. is 87 days.
Which FDA product codes appear under Applied Vascular Devices, Inc.?
The most frequent FDA product codes under this applicant name are DXC (Clamp, Vascular, 5); DXE (Catheter, Embolectomy, 2); DYB (Introducer, Catheter, 2).
Next steps
- See all 21 Applied Vascular Devices, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXC, Applied Vascular Devices, 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.