Volcano Atheromed, Inc.
6 product lines across 1 device categories: Atherectomy.
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Atherectomy Devices
Used in: Peripheral Atherectomy
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Phoenix 1.5mm x 149cm 4F Atherectomy Catheter | Outer Diameter: 1.5–2.4 mm; Length: 130–149 cm | 6 | Not stated |
| Phoenix 2.2mm x 130cm 6F Atherectomy System | Outer Diameter: 1.5–2.4 mm; Length: 130–149 cm | 6 | Not stated |
| Phoenix 2.2mm x 130cm 6F Deflecting Atherectomy Catheter | Outer Diameter: 2.2–2.4 mm; Length: 130 cm | 2 | Not stated |
| Phoenix 2.4mm x 130cm 7F Deflecting Atherectomy System | Outer Diameter: 2.2–2.4 mm; Length: 130 cm | 2 | Not stated |
| Phoenix 2.4mm 7F Deflecting Atherectomy Catheter | Outer Diameter: 2.4 mm; Length: 127 cm | 1 | Not stated |
| Phoenix 2.4mm 7F Deflecting Atherectomy System | Outer Diameter: 2.4 mm; Length: 127 cm | 1 | Not stated |
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FDA clearances and approvals
- 2 4mm x 130cm phoenix deflecting atherectomy system 1 5mm x 149cm phoenix atherectomy system 510K K211518, 2021
- 1 8mm x 149cm phoenix atherectomy system 2 2mm x 149cm phoenix atherectomy system 2 4mm x 130cm phoenix atherectomy system 510K K172386, 2017
- 1 8mm x 149 cm phoenix atherectomy catheter 2 2mm x 149 cm phoenix atherectomy catheter phoenix handle phoenix wire support clip 510K K143328, 2014
Product lines, models and sizes are compiled from the FDA Global Unique Device Identification Database (GUDID) and FDA clearance records. Descriptions marked "Provided by the manufacturer" come from the company and are reviewed before publishing.