Vascular Medcure, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Vascular Medcure, Inc.” (first 2019, latest 2020), across 1 product code in 1 review panel. Median 510(k) review time under this name: 29 days. Since 2017 the median was 29 days, against 67 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2019 | 2 | 65 |
| 2020 | 3 | 27 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Vascular Medcure, Inc. took a median 29 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 67 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | 5 | 5 |
Review panels
- Cardiovascular (5)
Most recent Vascular Medcure, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203476 | CAPERE Thrombectomy System | QEW | 2020-12-22 | 27 |
| K201216 | CAPERE Thrombectomy System | QEW | 2020-07-08 | 64 |
| K200314 | Capere Thrombectomy System | QEW | 2020-03-04 | 27 |
| K192935 | CAPERE Thrombectomy System | QEW | 2019-11-15 | 29 |
| K183179 | CAPERE Thrombectomy System | QEW | 2019-02-25 | 101 |
Recalls
openFDA lists no recalls under a recalling firm named Vascular Medcure, 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.
- Vascular Solutions, Inc. (115 510(k)s)
- Vascular Technology Incorporated (11 510(k)s)
- Vascular Control Systems, Inc. (9 510(k)s)
- Vascular Architects, Inc. (5 510(k)s)
- Vascular Pathways, Inc. (4 510(k)s)
- Vascular Flow Technologies, Ltd. (3 510(k)s)
- Vascular Products, Inc. (3 510(k)s)
- Vascular Graft Solutions, Ltd. (2 510(k)s)
- Vascular Insights, LLC (2 510(k)s)
- Vascular Designs, Inc. (1 510(k)s)
- Vascular Flow Technologies Limited (1 510(k)s)
- Vascular Intervention (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vascular Medcure, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Vascular Medcure, Inc.” (first 2019, latest 2020), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Vascular Medcure, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vascular Medcure, Inc. is 29 days. Since 2017: 29 days, versus 67 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Vascular Medcure, Inc.?
The most frequent FDA product codes under this applicant name are QEW (Peripheral Mechanical Thrombectomy With Aspiration, 5).
Next steps
- See all 5 Vascular Medcure, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QEW, Vascular Medcure, 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.