Walk Vascular, LLC: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Walk Vascular, LLC” (first 2012, latest 2022), across 1 product code in 1 review panel. Median 510(k) review time under this name: 113 days. Since 2017 the median was 112 days, against 101 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 |
|---|---|---|
| 2012 | 1 | 260 |
| 2013 | 0 | — |
| 2014 | 1 | 299 |
| 2015 | 0 | — |
| 2016 | 1 | 111 |
| 2017 | 2 | 112 |
| 2018 | 0 | — |
| 2019 | 2 | 112 |
| 2020 | 1 | 120 |
| 2021 | 0 | — |
| 2022 | 1 | 84 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Walk Vascular, LLC took a median 112 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 101 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QEZ | Aspiration Thrombectomy Catheter | 9 | 9 |
Review panels
- Cardiovascular (9)
Most recent Walk Vascular, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213565 | JETi AIO Peripheral Thrombectomy System | QEZ | 2022-02-01 | 84 |
| K201998 | JETi AIO Peripheral Thrombectomy System | QEZ | 2020-11-17 | 120 |
| K192439 | JETi Peripheral Thrombectomy System | QEZ | 2019-12-09 | 94 |
| K183403 | JETi 88 Peripheral Thrombectomy System | QEZ | 2019-04-17 | 131 |
| K172000 | ClearLumen II Peripheral Thrombectomy System | QEZ | 2017-10-24 | 113 |
| K163051 | ClearLumen II Peripheral Thrombectomy System | QEZ | 2017-02-21 | 112 |
| K161786 | ClearLumen II Thrombectomy System | QEZ | 2016-10-18 | 111 |
| K140296 | CLEARLUMEN THROMBECTOMY SYSTEM | QEZ | 2014-12-02 | 299 |
| K120508 | CLEARLUMEN THROMBECTOMY SYSTEM | QEZ | 2012-11-07 | 260 |
Recalls
openFDA lists no recalls under a recalling firm named Walk Vascular, LLC.
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.
- Walk-A-Cycle Division (1 510(k)s)
- Walk on Wheels Australia Pty, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Walk Vascular, LLC?
FDA lists 9 510(k) clearances under the applicant name “Walk Vascular, LLC” (first 2012, latest 2022), 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 Walk Vascular, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Walk Vascular, LLC is 113 days. Since 2017: 112 days, versus 101 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Walk Vascular, LLC?
The most frequent FDA product codes under this applicant name are QEZ (Aspiration Thrombectomy Catheter, 9).
Next steps
- See all 9 Walk Vascular, LLC clearances with predicates and recalls
- Run predicate analysis for product code QEZ, Walk Vascular, LLC'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.