Company ยท US
Volcano Atheromed, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2021. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 14, 2021 | K211518 | 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System Volcano Atheromed, Inc. | MCW |
| Apr 20, 2020 | K193197 | QuickClear Mechanical Thrombectomy System Volcano Atheromed, Inc. | QEZ |
| Dec 20, 2018 | K182972 | Phoenix Atherectomy System Volcano Atheromed, Inc. | MCW |
| Dec 17, 2018 | K181877 | Phoenix 2.4mm Atherectomy Plus System Volcano Atheromed, Inc. | MCW |
| Aug 24, 2017 | K172386 | 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy Sy Volcano Atheromed, Inc. | MCW |
| May 26, 2015 | K151145 | 2.4mm X 127 cm Phoenix Atherectomy Deflecting System Volcano Atheromed, Inc. | MCW |
| Dec 19, 2014 | K143328 | 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire S Volcano Atheromed, Inc. | MCW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||