Velocimed, Inc.: FDA clearances and approvals
Velocimed, Inc. has 6 FDA 510(k) clearances (first 2003, latest 2006), across 3 product codes in 1 review panel. Median 510(k) review time: 165 days.
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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 4 | 4 |
| DYB | Introducer, Catheter | 1 | 1 |
| NFA | Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection | 1 | 1 |
Review panels
- Cardiovascular (6)
Most recent Velocimed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K052523 | PROXIS SYSTEM | NFA | 2006-09-07 | 358 |
| K043084 | PREMERE DELIVERY SHEATH, MODEL PDS | DYB | 2005-05-02 | 175 |
| K042117 | PROXIS SYSTEM, MODEL EPS 101 | DQY | 2005-01-07 | 155 |
| K042910 | VENTURE WIRE CONTROL CATHETER, MODEL WCC | DQY | 2004-11-22 | 32 |
| K040922 | VENTURE WIRE CONTROL CATHETER | DQY | 2004-08-18 | 132 |
| K023548 | PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101 | DQY | 2003-08-04 | 286 |
Recalls
openFDA lists no recalls under a recalling firm named Velocimed, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Velocimed, Inc. have?
Velocimed, Inc. has 6 FDA 510(k) clearances (first 2003, latest 2006), across 3 product codes in 1 review panel.
How long does FDA take to clear Velocimed, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Velocimed, Inc.'s cleared 510(k)s is 165 days.
What devices does Velocimed, Inc. make?
Its most frequent FDA product codes are DQY (Catheter, Percutaneous, 4); DYB (Introducer, Catheter, 1); NFA (Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection, 1).
Has Velocimed, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Velocimed, Inc. Related entities may recall under other names.
Next steps
- See all 6 Velocimed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQY, Velocimed, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.