Volcano Atheromed, Inc.: FDA clearances and approvals
Volcano Atheromed, Inc. has 7 FDA 510(k) clearances (first 2014, latest 2021), across 2 product codes in 1 review panel. Median 510(k) review time: 29 days. Since 2017 its median was 55 days, against 94 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 29 |
| 2015 | 1 | 27 |
| 2016 | 0 | — |
| 2017 | 1 | 16 |
| 2018 | 2 | 106 |
| 2019 | 0 | — |
| 2020 | 1 | 152 |
| 2021 | 1 | 28 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Volcano Atheromed, Inc.'s cleared 510(k)s took a median 55 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 94 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MCW | Catheter, Peripheral, Atherectomy | 6 | 6 |
| QEZ | Aspiration Thrombectomy Catheter | 1 | 1 |
Review panels
- Cardiovascular (7)
Most recent Volcano Atheromed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211518 | 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System | MCW | 2021-06-14 | 28 |
| K193197 | QuickClear Mechanical Thrombectomy System | QEZ | 2020-04-20 | 152 |
| K182972 | Phoenix Atherectomy System | MCW | 2018-12-20 | 55 |
| K181877 | Phoenix 2.4mm Atherectomy Plus System | MCW | 2018-12-17 | 157 |
| K172386 | 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System | MCW | 2017-08-24 | 16 |
| K151145 | 2.4mm X 127 cm Phoenix Atherectomy Deflecting System | MCW | 2015-05-26 | 27 |
| K143328 | 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip | MCW | 2014-12-19 | 29 |
Recalls
openFDA lists no recalls under a recalling firm named Volcano Atheromed, 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 Volcano Atheromed, Inc. have?
Volcano Atheromed, Inc. has 7 FDA 510(k) clearances (first 2014, latest 2021), across 2 product codes in 1 review panel.
How long does FDA take to clear Volcano Atheromed, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Volcano Atheromed, Inc.'s cleared 510(k)s is 29 days. Since 2017: 55 days, versus 94 days for all cleared 510(k)s in the same product codes.
What devices does Volcano Atheromed, Inc. make?
Its most frequent FDA product codes are MCW (Catheter, Peripheral, Atherectomy, 6); QEZ (Aspiration Thrombectomy Catheter, 1).
Has Volcano Atheromed, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Volcano Atheromed, Inc. Related entities may recall under other names.
Next steps
- See all 7 Volcano Atheromed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MCW, Volcano Atheromed, 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.