Vertex Medical Corp.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Vertex Medical Corp.” (first 1982, latest 1984), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 46 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 |
|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | 7 | 7 |
| DQO | Catheter, Intravascular, Diagnostic | 6 | 6 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
| DYG | Catheter, Flow Directed | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| LJE | Catheter, Nephrostomy | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Vertex Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K833742 | ESCHMANN DILATION CATHETER | — | 1984-04-24 | 181 |
| K834476 | NEPHROSTOMY/BILIARY DRAINAGE BAG | LJE | 1984-02-04 | 46 |
| K832380 | PROTECTIVE SLEEVE | DYG | 1983-11-28 | 132 |
| K831666 | SIALOGRAPHY NEEDLE | — | 1983-07-12 | 50 |
| K830576 | LYMPHANGIOGRAPHY SET | DQO | 1983-03-17 | 22 |
| K830420 | POLYETHYLENE MONITORING CONNECTORS | DQO | 1983-02-28 | 20 |
| K830237 | TRANSLUCENT POLY. CATH. CONNECTOR AND | DQO | 1983-02-18 | 24 |
| K823340 | CLEAR VINYL MONITORING CONNECTOR | DXT | 1982-12-30 | 52 |
| K823256 | ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE | DXT | 1982-12-30 | 59 |
| K823254 | REUSABLE METAL STOPCOCK | DXT | 1982-12-30 | 59 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Vertex Medical Corp..
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.
- Vertex Technical Group, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vertex Medical Corp.?
FDA lists 21 510(k) clearances under the applicant name “Vertex Medical Corp.” (first 1982, latest 1984), across 9 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 Vertex Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vertex Medical Corp. is 46 days.
Which FDA product codes appear under Vertex Medical Corp.?
The most frequent FDA product codes under this applicant name are DXT (Injector And Syringe, Angiographic, 7); DQO (Catheter, Intravascular, Diagnostic, 6); DQX (Wire, Guide, Catheter, 1).
Next steps
- See all 21 Vertex Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code DXT, Vertex Medical Corp.'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.